Pharmaceutical and Medical Packaging News
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Originally Published December 1999
MEDICAL
Medical Packaging Roundtable: Managing ISO 11607
It has been more than a year since FDA recognized as an official guidance the standard ANSI/AAMI/ISO 11607: 1997, "Packaging for Terminally Sterilized Medical Devices." Although the document is not an exact checklist specifically stating the steps to validating packaging and packaging processes, many in the medical device industry have welcomed it. The standard legitimizes the activities that packaging engineers have long performed to design, manufacture, and evaluate finished medical device packaging. Packagers finally have a bible outlining their responsibilities. Armed with ISO 11607, packagers can now justify their choices in materials as well as test methods, which in an era of cost-cutting are repeatedly questioned.
In this exclusive roundtable discussion moderated by DuPont Medical Packaging Systems's president Michael H. Scholla, PhD, six medical device packagers, who range in responsibility from engineer to department head, discuss how ISO 11607 has affected their packaging operations. The participants are Mike Johnson, packaging and labeling development manager for United States, DePuy, Johnson & Johnson Co.; Hal Miller, director of packaging technology, Johnson & Johnson Co.; Kevin Mulligan, director of packaging, Tyco Healthcare; Russ Riescher, senior packaging engineer, Bard Urological Division, CR Bard Inc.; James Sparks, senior packaging engineer, Baxter Cardiovascular Group; and John Spitzley, associate fellow of packaging, Medtronic. These distinguished panelists touch upon materials qualification, process validation, machinery calibration, package integrity testing, stability studies, expiration dates, and outsourcing, among other things.
While ISO 11607 has often been criticized for its lack of specificity, the roundtable participants appreciate the fact that the standard enables them to develop an implementation and adherence program tailored to their own packaging departments.
"If you submit under the abbreviated 510(k) program and declare conformity to ISO 11607, FDA is not allowed to ask questions unless the reviewer has obtained division approval." Michael H. Scholla, PH, president, DuPont Medical Packaging Systems, Wilmington, DE. |
To obtain a copy of the standard, contact the Association for the Advancement of Medical Instrumentation at 703/525-4890, or visit http://www.aami.org. AAMI has also produced a technical information report on the standard, AAMI TIR No. 22—1998.
How well has ISO 11607 been embraced by your organization in the packaging function?
Johnson: Being relatively new to the DePuy organization, with DePuy being relatively new to Johnson & Johnson, I was interested to see how deeply rooted ISO 11607 really is in the organization. I found that most everybody who is involved in packaging has read through it and understands and appreciates the standard terminology; they appreciate the framework. I think the application side of it is something that we're still trying to improve. We're striving to meet the standard, and I think we're well down the road. Organizationally, we're not quite where we want to be, but we will be soon.
Miller: Because I was involved early on with this particular document, I had the advantage of seeing what was coming. Here at Johnson & Johnson with the medical device companies, we established our own sterile medical packaging policy, which embraced some of the key essentials of ISO 11607 even before it was published; and therefore the companies have been using the concepts for quite some time now.
Mulligan: Our organization has grown significantly over the last several years through acquisition. When you take a look at the number of different philosophies within the different companies and make comparisons between the way we do things and 11607, there are a lot of similarities. A lot of the tenets of 11607 had been used not only by our company but also by several other companies that we had merged with. Certain elements are changing within our organization, including sample size. But the main tenets are very similar and have been in place for a long time.
Riescher: As soon as this document came out, we aggressively formed a committee and began looking at the document, and it's been an interesting ride. As the chairman of this committee, I've started talking to many of the porous membrane—component manufacturers, and I sometimes find that I'm the only person asking the questions, and it's kind of tough to be the guinea pig. But it's an interesting document and a great cookbook as to how to do package validation qualification.
Spitzley: We've been in a pretty rapid acquisition frenzy here lately, and it's interesting to compare where the newer companies that we've acquired are in relation to this document as compared to our core groups here, the largest organizations that were part of Medtronic for many years. There's clearly a stratification—some of the newer acquisitions are relatively smaller and probably aren't where they need to be in terms of their knowledge of 11607, and some of them are fully aware of it and have embraced it—so there's a lot of variability in how a lot of our companies are embracing 11607.
Sparks: Looking back at protocols, back through the 1990s and the late 1980s, most of the testing that was done was within 11607; I think now 11607 ties it all together. You can pull this document out and say, this is how we need to lay out the protocol. As a packaging engineer working in the trenches, I now have help in going to the quality and the regulatory people with a plan to validate packages.
"At Medtronic, there's clearly a stratification—some of the newer acquisitions are smaller and probably aren't where they need to be in terms of their knowledge of ISO 11607, and others have fully embraced it." John Spitzley, associate fellow of packaging, Medtronic, Minneapolis. |
One of the criticisms about ISO 11607 is that it's not a check sheet. Have you taken the document and established your own criteria to make it into a check sheet?
Spitzley: We have established internal test procedures and engineering documentation that did specify our own pass/fail criteria for certain package attributes, so in effect you're right: the ISO document has given us a framework to address those requirements. For some companies who were long under GMPs, they were required to have those documents around anyway, and now that we've got 11607, it just gives us a nice way to package it.
Riescher: I like the flexibility that the document allows. In a way the flexibility is great because it gives you a guideline but doesn't dictate that you've got to do it exactly this way; it allows for different methods to be tried.
Johnson: I remember seeing 11607 for the first time, and to me it paralleled very closely an essential requirements checklist. Not so much a check sheet, where you just tick them off one at a time, but rather it seemed to parallel the ISO approach. I embraced that, and to me that's more in line with what the document is intended to do—to provide guidance.
The first step to packaging a new device is design control. Has ISO 11607 influenced your design controls at all?
Miller: We had good design control with our packaging documention all along because it was part of the whole documentation package, so it really wasn't anything new for us. I would guess that's probably true for any of the major companies that have been around for quite a while. I think where it becomes important and meaningful is for the newer, smaller companies that may not have had design control extended into their packaging area.
Riescher: For my design control protocols, it has given me a stronger link to my supplier to whom I may never have mentioned microbial challenge testing of materials before. I'm more inclined to put that in now.
Mulligan: In my opinion, this is perhaps the best document in terms of formalizing what pretty much had been done throughout the industry for years.
How well are your materials suppliers doing in giving you what you need to demonstrate that their materials comply with 11607?
Riescher: When I set up our compliance program, the first thing I started to do was to have discussions with Mangar, Rexam, and Perfecseal to start looking at the porous membrane. What I found out is that they're using the ISO document as a framework internally for doing their material qualification or validation. I'm actually asking them for a certificate of compliance that states that their materials meet some of these requirements.
Miller: I believe many of the J&J companies right now are looking at and have established their own requirements over the years as to what truly the requirements are for packaging materials. As a result, they have established that certain attributes or physical properties are critical to the manufacturer. Companies must have requirements for incoming inspection, and then they must ensure that the material is suitable for device packaging.
Mulligan: The vendors certify the raw material against a specific set of requirements, and they'll provide certain sets of data, but for the most part, they leave it up to the device manufacturer to pull the processing pieces together. It's really up to the manufacturers to determine whether the package is acceptable or not.
Miller: Vendors put out a product sheet on the material's basic physical properties; it might be seal strength, it might be tensile strength, etc. The porous material manufacturers should have the microbial barrier information. However, once it gets beyond that, you process and seal their materials.
Mulligan: At that point the suppliers would probably try to limit their involvement. Historically they leave it up to the medical device manufacturers to qualify and process validate on their equipment.
Miller: It would make sense that they would only be obligated to give you specific data about the material as they manufacture it. Once the material leaves their premises, if it is converted, then it's out of their control. Down the line, the manufacturers who use the material are certainly throwing in all kinds of variables, like sealing, sterilization, and other handling processes. It's clearly stated in the standard—the producers of the raw material are limited in what kind of information they can provide.
Scholla: Converters limit the amount of information they share because it's just overwhelming. In Tyvek, we have three styles that we sell for medical packaging. Developing an ISO 11607 compliance document for three styles took an incredible amount of work. We're in the final stages, and it's out for review right now. Converters have thousands of stock-keeping units. It's just impossible to have all of that information ready for somebody who asks. That said, there is no reason anybody should be running tests for microbial barrier properties on the porous part of their package after sterilization. That information should be obtained from the materials supplier.
Sparks: What we've tried to do is use ISO 11607 to standardize a set of general notes, indicating what we are going to require from the vendor.
Riescher: The supplier's role might increase marginally, but ultimately it's my responsibility for package integrity, so I think that the whole ISO document and the tone of it are predominantly weighted toward the manufacturer. For that reason, I think we're always going to have the most to deal with.
Johnson: I think the major companies like DuPont are doing a pretty good job. I think there are still some intermediate suppliers who maybe don't understand the document as well as they should and rely upon us as the manufacturers to help them interpret and understand it a little better. The burden can be shouldered from both sides of the fence here.
"Some intermediate suppliers don't understand the document as well as they should, and they rely upon us as the manufacturers to help them interpret and understand it better." Mike Johnson, packaging and labeling development manager for United States, DePuy, Johnson & Johnson Co., Warsaw, IN. |
What are some of the things that suppliers aren't giving you?
Johnson: We're really trying to work with a local supplier, and we're trying to educate the company on the total concept of materials, design, and process. There's already been a lot of groundwork that's been done by its suppliers, but the firm just doesn't understand that. So we tell the firm, "You really need to understand better about your process because you can affect the materials that you're getting from a major supplier." We have a large number of suppliers, and there are a lot of old relationships that we don't want to throw out, so we want to try to leverage those where we can and separate those by risk.
Spitzley: We're moving toward establishing commodity teams to take a look at the supply chain for packaging materials used in the past. As our company gets larger, more suppliers want to do business with us, and it's helpful to have a document like this to tell the whole story. If there's pressure to change a material or supplier because of price, the pressure on engineering becomes pretty intense. At least with the ISO document, we can now point out that there are a lot of hidden costs. It's not simple to make the switch. You have to qualify the material and determine the effect on sterilization and manufacturing.
How many of you could easily declare compliance to ISO 11607 on a new product? For an abbreviated 510(k) application?
Spitzley: I think we could.
Miller: The whole issue in 510(k) [premarket notification] and PMA [premarket approval] submissions comes down to design control. If you have appropriately qualified your packaging product, are ready for market, and are following appropriate QSR [quality system regulation] design control issues, I think you're in line with ISO 11607.
Riescher: That's what we're striving for.
Mulligan: What's the advantage to making that statement?
Miller: What it does, Kevin, is that if you certify to meeting the requirements of ISO 11607, in essence what you've said to FDA is, we do all of the elements of this particular document. The intent was to try to facilitate and minimize the amount of questions.
Scholla: More importantly, if you submit under the abbreviated 510(k) program and declare conformity to a recognized standard—and ISO 11607 is a recognized standard—FDA is not allowed to come back to you and ask questions unless the reviewer has gone up two levels in the hierarchy and obtained division approval. You're saying that you're complying with ISO 11607. They have to accept that. And then, during a field inspection, they can ask you to produce the documentation demonstrating compliance to 11607, but the reviewer doesn't do it.
Mulligan: My experience has been that typically with the products that we manufacture, rarely do we get questions on packaging. I don't know if that's similar to the rest of the group or not. In fact, I think in all the time I've been at this company, there have been maybe three or four questions over many years, and they were very simple and could be answered quickly.
Spitzley: I wish I could say that were true for us. We get quite a few questions on packaging. Even when we are submitting a product that is very similar to another product and we've maybe changed configuration—no major changes in materials—we'll still get questions. And it can be pretty time-consuming. Because of that, when we do the initial PMA submittals, we do quite a bit of work in packaging, and then if there are follow-up questions, it just takes time to do the research and get the answers in the right format.
Mulligan: I think you hit the nail on the head, though, when you said PMA. The types of products we manufacture are typically Class I, Class II, a few Class III, but when you get into Class III and PMA types of products, clearly you may be more apt to have those kinds of questions.
Spitzley: Yeah, you're right there. In fact, I think there have been some discussions about transitioning this program ultimately to PMA submittals.
In terms of validating your process and your machinery, has ISO 11607 caused you to change the way you do things, or has it just established a good framework for developing your own protocols?
Riescher: Well, for me at Bard, it's confirmed that we're on the right track.
Mulligan: I think very much the same. It just confirms what we've been doing and formalizes it a bit better.
"Vendors certify raw packaging materials against a specific set of requirements, but for the most part, they leave it up to the device manufacturers to pull the processing pieces together." Kevin Mulligan, director of packaging, Tyco Healthcare, Mansfield, MA. |
Does that give you a great deal of credence within your own companies?
Mulligan: I think it's a reaffirmation.
Riescher: I think that's very important. We were audited by FDA not long ago, and even though I couldn't say I had everything in place for ISO 11607 compliance, I still talked to the auditor about it. At least there were some things that I could show him and say, we don't have this compliance program totally in place, but we are pursuing it.
Miller: Has there been any issue with notified bodies for CE marking with ISO 11607? Do they use it?
Johnson: They want to make sure that we understand it and are using it and are familiar with the European standards, but we have yet to be audited in this area.
Scholla: Has anybody else worked with notified bodies?
Mulligan: I've never been directly asked the question, "Are we in compliance with 11607?" We have several notified bodies within the company, and they've reviewed all of the things that we do. The only thing I can say is, since what we have for the most part is already in line with 11607, there really haven't been any significant questions beyond what you are typically asked to show as part of audits.
One of the most difficult things about ISO 11607 is deciding what test methods to use. Are all of you happy with the test methods that you're using? As an industry, are we doing the right things in terms of standardizing test methods?
Spitzley: ASTM did a good job of jumping on the tests that needed standardization based on the issues that came up when we were writing this document and then on our efforts for switching over from microbial challenge to physical test methods. When we did that, as an industry, we discovered that we really needed to standardize some of our physical test methods. Now we've got standardized tests for visual inspection and dye penetration. In terms of package strength, I think they've done some work on standardizing and updating the burst test. So I think they did a pretty good job of getting those test methods up to speed when ISO came out.
Miller: What the ASTM committee F2.60 for medical packaging attempted to do was to take a look at what test methods were cited in ISO 11607 and standardize those particular test methods. Since FDA recognized ISO 11607 as a consensus standard, it may ask for supplemental information on things such as identification of tests and results of testing. So if there are standardized tests from ASTM, for instance, then maybe they won't ask us for as much information, particularly on the issues of validation and test appropriateness and sensitivity.
"The supplier's role may increase marginally, but ultimately it's my responsibility for package integrity. ISO 11607 is predominantly weighted toward the manufacturer." Russ Riescher, senior packaging engineer, Bard Urological Div., CR Bard Inc., Covington, GA. |
How much of the work must be repeated by a user of a recognized standard in terms of the precision and sensitivity rather than on repeatability and the ability to conduct the test?
Miller: Let me give you the official ASTM position right now. The intention of the test method needs to be determined. For what materials is it applicable, meaning pouches or blisters, porous or nonporous? What is the sensitivity of this particular test method that we have demonstrated? This establishes with authorities the limitations of the test. We do look at reproducibility—in other words, lab-to-lab precision, for instance—but what it comes down to is that you still need to validate the test method in your own laboratory.
Scholla: Validation of packaging test methods was not something we worried about five years ago. Even a test as simple as dye penetration wasn't standardized until recently.
Miller: Analytical test methods that scientists tend to use are very easy to validate because there are actual precision results. You have a test sample that you can run and compare it to and make sure you always get benchmark gold standard—type results. But in physical tests, it's much more difficult. I think that's one of the problems with validating physical tests.
In terms of equipment available today, do you find that the bells and whistles on machinery affect what you buy and your rationale for performing package testing?
Riescher: In some cases, if there's an automatic calibration system, it would give me a time advantage I'd be interested in pursuing.
Johnson: The quantifiable information from that process is extremely important. I think any equipment manufacturer that really doesn't address that is starting to raise concerns about its technical ability and its knowledge of process validation. It is real important, and I concur with what Russ said—turnkey validation or calibration is a nice time-saver.
Scholla: So, the companies that aren't there yet—
Mulligan: Are at a disadvantage.
Johnson: Absolutely.
Sparks: When ISO 11607 came out, there was that one statement: "There shall be the ability to monitor key parameters." We spent a lot of money just trying to comply with that one statement.
Scholla: Did it improve your process?
Sparks: I think so. We really didn't have control over the process with a lot of the old packaging equipment. You could see differences with just a visual inspection of the seal. The new equipment has given us a good handle on validating our processes.
"If you have appropriately qualified your packaging product, are ready for market, and are following appropriate QSR design control issues, you're in line with ISO 11607." Hal Miller, director of packaging technology, Johnson & Johnson Co., New Brunswick, NJ. |
How much microbial barrier testing of materials do you perform?
Spitzley: We don't. We have no interest in it. We do physical tests. Now you're referring to physical versus microbial challenge in evaluating stand-alone materials, is that correct? Or are you talking about the physical versus microbial in evaluating the whole package?
Scholla: Both.
Spitzley: For a whole package, of course, we do our own testing—we're doing strictly physical test methods now. For several years, of course, we did microbial challenge testing on packages when we were doing shelf life or package qualifications. We no longer do that, since it's no longer a requirement, so we now do physical test methods. But we have no interest in evaluating stand-alone materials.
Miller: When you're in a global company and you're using a lot of paper, you find that people want to try to substitute and go where there would be cost advantages, so they try local suppliers around the world. What we have found over the years is that we are constantly evaluating the microbial barrier properties of materials and comparing them to that of existing materials. Anytime you use paper as a primary packaging material around the world, this is going to happen.
Mulligan: I agree. We pretty much do the same thing. We actually do both in combination. We'll do a variety of different physical tests depending upon the nature of the substrates that we're working on, and then we'll do the full package test or even just the material.
Scholla: Do you usually run this test poststerilization?
Mulligan: We do both pre- and poststerilization, particularly if it's a new material.
Scholla: As producers, then, you actually evaluate materials along with the whole package, especially if you're going to use a new material.
Miller: There are also circumstances in which people are looking for substitutions for Tyvek, for instance, so they're looking at alternative paper products that are reasonably new. As a result, there's not a lot of background on them, so you have to do microbial challenge.
Mulligan: Also, a lot of companies are moving more toward gamma radiation sterilization. Film-to-film packages or hermetically sealed packages are starting to become popular. There are differences obviously when you compare hermetically sealed packaging systems to porous packaging systems.
"As a packaging engineer working in the trenches, I now have help in going to quality and regulatory people with a plan to validate packages." James Sparks, senior packaging engineer, Baxter Cardiovascular Group, Irvine, CA. |
What challenges do you face in producing a validation protocol?
Riescher: One issue that we never completely agree on is what sample size to use for transit testing. Right now, I evaluate each product independently, but it's a tough question to answer when producing a protocol.
Miller: Particularly when you only ship one-of-a-kind products.
Riescher: Sure, what if you have a very expensive electronic monitor, which I sometimes do? That's always tough.
Miller: Or the other issue is if your distribution method is to send one device out as part of an order with many other devices, you have a different protocol to follow for package performance testing and sample size.
Riescher: Yeah, I face that all the time.
Miller: The only thing you can do there is establish what your worst-case condition would be and test to that.
Scholla: But sometimes, it's difficult to imagine what the worst-case condition might be. For example, we helped a customer who was blowing seals on Tyvek pouches. As it turned out, if the forklift operator set the pallet down too hard and if the boxes on the bottom of the pallet had too many units inside, the pressure was such that the seals blew on about 25% of the pouches in the bottom box. Now, I wouldn't have imagined that to be the worst-case scenario. So, what is worst case?
Spitzley: You can only establish to the best of your ability reasonable confidence and reliability intervals. However, there are no guarantees, particularly when you get into situations in which you don't have the sample size needed to get the highest level that you'd like to get to, but you can only work with the tools that they give you.
Miller: I think we're referring to worst-case as far as how it's packed for testing, but typically in package performance testing we're trying to look at what the package normally will see under distribution and handling conditions. And then, how do you combine that with worst-case scenario? So, are we going to go to much more expensive or intricate packaging in order to protect this particular product from the worst-case condition? There's a fine line there.
Sparks: One of the big problems we had a few years ago when following the ISTA/ASTM standards was that we were failing a lot more product in the lab than was historically ever being returned from the customer as failures in the field. We monitored our distribution environment with units that measure drop heights and vibrations. We found that what we were doing, following the test standards, represented what the packages were seeing in the field. In some cases, it was worse in the field. ISO 11607 confirmed the testing we were performing.
Spitzley: I always found it interesting that there are hundreds of tests performed on the device, from the beginning of its cycle until the end. It's always a given that one of the test outcomes may be "Fail." But with packaging, the only allowable outcome is "Pass."
Mulligan: Right.
Spitzley: If we fail the packaging test, we're asked, how can that be? Well, it can be because we're no different from any other component upstream. But the one thing about ISO 11607, it does give you some credibility—we're just as important as any other product component.
Are there any other trends creating a quandary for you?
Mulligan: The standard alludes to expiration dating of product and stability testing. As I mentioned before, a lot of the products we typically make are Class I and Class II that, in the United States market at this particular time, we're not required to expiration date. But the trends may be changing. Maybe I can direct this to Hal: Do you see the same kinds of issues facing J&J, particularly with those Class I or Class II products?
Miller: I really can't speak to the issue of trying to manage inventories at this point. But for a product to carry the CE mark, it must bear an expiration date. I have heard of instances where FDA has even asked on PMAs for expiration dating on a product, under the premise, if sterility truly lasts forever, prove that you have integrity forever. So as a result, you may end up having to create an expiration date for those purposes.
Johnson: I agree with you. One of the driving forces is the CE mark. DePuy as an organization is considering whether to present just one package that does indeed have expiration dates. But there are a lot of consequences from an operations standpoint.
Mulligan: Obviously for the CE-marked products, you're going to try to run product out of a common inventory if you can. But for products that you may never have intended to sell internationally, do you treat them separately, under a separate set of rules, or do you evolve toward one common set of rules for expiration dating?
Miller: The other issue goes into multilingual labeling. Do you start to split lots and have specific packages with country-specific labeling, or do you do everything as a global package with all the languages? The same issues would hold true for expiration dating, depending on what type of system you have. Those who manufacture and ship around the world, I think, tend to try to standardize and have only one set of rules.
Mulligan: Many companies are struggling with finding the right approach, particularly when you've got a lot of regulatory changes not only in Europe but potentially in the Pacific Rim, who may develop its own version of CE.
Scholla: From a packaging perspective, if you don't typically expiry date your products, you're not required to have stability studies for them.
Mulligan: Technically, for certain products that can be correct, but it is somewhat ironic.
Scholla: Yes. But FDA says you don't need to have them. If you put an expiry date on your products, you must have a stability study that's as long as the expiry date. So you put the date on to satisfy the European requirements, and then you find out you don't have a stability study.
Mulligan: Expiration dating a medical device requires adequate stability data to support that claim. Efficacy of the product must be demonstrated to support the proposed shelf life. Presently, Class I and Class II products marketed in the United States do not require expiration dating, while the same products marketed in Europe do. As companies move toward cost-effective approaches with common inventories, many of those same Class I and Class II products will begin to show expiration dates in the U.S. market.
Scholla: I look at different approaches that customers have taken. They start with a one-year expiry date because they had enough data to do that. Then after two years they change it to two, and after three years they change it to three. But I've also seen people run accelerated aging and put five years on it and hope for the best. It's definitely a mixed bag, and you end up confusing your customers. Gee, this product's got a date on it; this one doesn't. What does that mean?
How many people expiry date their packaging because they're going to lose package integrity after that amount of time?
Mulligan: I would venture a guess to say none.
Scholla: I would also venture a guess to say none. The reason companies put an expiry date on a package is the device isn't going to work anymore, for example, maybe for one of John's pacemakers with a battery, right?
Spitzley: That's correct.
Scholla: That's a good reason for putting an expiry date on a package. But the main reason is the EU says you must put it on there. So companies pick an arbitrary time frame that they think is reasonable for that package to be used up in the marketplace. And that's anywhere from three years to five years.
Mulligan: Certain customers may prefer to have expiration dates on packaging. They rotate their inventory according to the dates. They have to put expiration dates on their products, and I'm talking about hospitals in which they do their own kit packing and sterilization.
Riescher: I'd like to ask a question. How far away are we from harmonization of ISO 11607 and EN 868-1?
Scholla: And by harmonization you mean a single document?
Riescher: Yes.
Scholla: I'm not sure we'll ever have a single document. The scope of the ISO document includes process, and the scope of the EN document doesn't. And the ISO document also indicates that healthcare facilities are considered manufacturers; the EN document does not. Those two philosophical differences will always result in two documents.
Miller: Well, one of the difficulties I have with EN 868-1 is that it does not even come close to complying with the Medical Devices Directive. And as a result, then, when the EN group took off and was mostly medical material manufacturers, it did not incorporate the medical device industry, for which the Medical Devices Directive was targeted. I think ISO 11607 is the one that best complies with the directive.
Scholla: I would agree with you, Hal.
Miller: So the question becomes, rather than fight with the specific CEN working group, do you discuss it with higher European authorities? EN 868-1 won't go away; it will always be there. But will it be mandated as part of the directive? I think politics could play an issue here.
Scholla: It's a long way off. If you want to manufacture a device for sale in both the United States and in Europe and you look at the updated version of 11607, it's pretty clear what you must do to make both things happen.
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