Medical Device & Diagnostic Industry
Articles by Category - Standards
2002 | 2001 | 2000 | 1998 | 1993 | 1992 | 1990 | 1989 | 1988 | 1987 | 1986 | 1985 | 1984 | 1983 | 1982
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2002
- (News & Analysis) Industry Confronts Challenge from New Testing Standard, Leslie Laine (MDDI, Oct 2002, p. 22). Keyword: Testing.
- (Editor's Page) Are You Making a Product or a Process? (MDDI, Oct 2002, p. 14). Keyword: Industry.
- Understanding the New EMC Standard for Medical Devices: What Manufacturers Need to Know Now, Jon Sherratt (MDDI, Aug 2002, p. 50). Keywords: Regulatory Affairs.
2001
- (MPB) Considerations for the Biocompatibility Evaluation of Medical Devices, Raju Kammula (MDDI, May 2001, p. 82). Keyword: FDA.
- Human Factors Roundtable Part II: Standards Development and Implementation (MDDI, Feb 2001, p. 90). Keywords: Regulatory Affairs.
2000
- (ISO 10993) Biocompatibility Safety Assessment of Medical Devices: FDA/ISO and Japanese Guidelines, Vasudev Anand (MDDI, Jan 2000, p. 206). Keywords: ISO 10993.
1998
- A Practical Guide to ISO 10993-11: Designing Subchronic and Chronic Systemic Toxicity Tests, Louis E. Sendelbach (MDDI, Sep 1998, p. 102). Keywords: ISO 10993.
- A Practical Guide to ISO 10993-6: Implant Effects, Richard Wallin (MDDI, Aug 1998, p. 102). Keyword: Testing.
- Using IEC 60601-1-2 for Testing Medical Devices, Gary Fenical (MDDI, Aug 1998, p. 56). Keyword: electrical.
- The Differences between U.S. and E.U. Laser Standards, Karl J. Hejlik (MDDI, Aug 1998, p. 54). Keyword: International.
1993
- Suppliers Pursue ISO 9000 Registration, Greg Freiherr (MDDI, Oct 1993, p. 77). Keyword: ISO9000.
- Single Market for Medical Devices (A), Mika Reinikainen (MDDI, Mar 1993, p. 30). Keywords: International Affairs, European.
- Federal Standard 209E: Plan for Change, Robert J. Pellizzi (MDDI, Feb 1993, p. 40). Keyword: Cleanrooms.
- International Electronics Standards: Compatibility or Interference, Cliff Henke (MDDI, Feb 1993, p. 36). Keywords: Electronic Devices.
- Alphabet Soup of Standards (An), John Bethune (MDDI, Feb 1993, p. 8). Keyword: European.
- News: New ISO Release to Supplant Tripartite (MDDI, Jan 1993, p. 22). Keyword: European.
- News: Global GMP May Become Reality (MDDI, Jan 1993, p. 14). Keyword: Harmonization.
1992
- Guest Editorial: Wanted: A U.S. policy on international standards, Amiram Daniel (MDDI, Dec 1992, p. 18). Keyword: Harmonization.
- ISO 9000: Choice or Necessity?, Cliff Henke (MDDI, Oct 1992, p. 44). Keywords: Quality, Standards Setting, Harmonization, ISO9000.
- News: Federal Standard 209E release imminent (MDDI, Jun 1992, p. 22). Keyword: FS209.
- News: Move to a world TQM standard? (A) (MDDI, Jun 1992, p. 12). Keywords: Quality, ISO9000.
- News: ISO standards far along, officials report (MDDI, May 1992, p. 13). Keywords: Sterilization, Standards Setting, Standards.
- Sterility and safety assurance of medical devices, Robert F. Morrissey (MDDI, Apr 1992, p. 78). Keywords: Sterilization, Standards, Sterility Assurance.
- Face to face with FDA: an interview with Philip B. White, Director, Office of Standards and Regulations, CDRH, Cliff Henke (MDDI, Apr 1992, p. 22). Keywords: Harmonization, Standards, International Affairs.
- News: First international packaging standards in draft stage (MDDI, Jan 1992, p. 18). Keywords: Standards, Packaging.
1990
- Market Report: Medical device sterilization in the EC, Pieter Halter (MDDI, Aug 1990, p. 38). Keywords: Sterilization, Standards, CFCs.
- News: ISO approves medical device committee, Greg Freiherr (MDDI, Aug 1990, p. 28). Keywords: Sterilization, Standards Setting, Standards.
- International standards: harmonizing to a European tune, Gary M. Stephenson (MDDI, Jun 1990, p. 97). Keywords: Harmonization, International Affairs, European.
- News: Occupational radiation standards may toughen (MDDI, Jun 1990, p. 32). Keywords: Occupational Safety.
- News: Participants needed to develop glove standards (MDDI, Feb 1990, p. 20). Keywords: Gloves, Standards Setting.
1989
- American and European standards: the crossroads, John Anderson (MDDI, Apr 1989, p. 14). Keywords: Harmonization, Standards, European.
1988
- News: Electromedical safety standards reexamined, David Haut (MDDI, Sep 1988, p. 31). Keywords: AAMI, Electronic Devices.
- News: CITEHC: a boon or a bane to industry? (MDDI, Jan 1988, p. 120). Keywords: CITEHC, Standards Setting, Standards.
1987
- Comment [on the proposed revision of Federal Standard 209B], David Haut (MDDI, Feb 1987, p. 42). Keywords: Cleanrooms, FS209.
- Proposed revision of Federal Standard 209B (The), Robert D. Peck (MDDI, Feb 1987, p. 32). Keywords: Cleanrooms, FS209.
1986
- Regulating through voluntary standards, Michael J. Miller (MDDI, Aug 1986, p. 8). Keywords: AAMI, Voluntary Standards.
- USP as a tool for standardizing devices, William M. Heller (MDDI, Jun 1986, p. 74). Keyword: USP.
- Effect of standards on the design of electromedical devices (The), Robert D. Gold (MDDI, May 1986, p. 28). Keywords: Electronic Devices.
1985
- Standards: a new look for a new era, David M. Link (MDDI, Jul 1985, p. 8). Keywords: Voluntary Standards, Standards Setting.
- Hazard communication: an appropriate response, Michael L. Rataj (MDDI, Jun 1985, p. 26). Keywords: Occupational Safety.
- Recent California occupational safety and health regulatory developments on EtO, Joel K. Wong (MDDI, Apr 1985, p. 34). Keywords: Et O, California, Occupational Safety.
1984
- Federal Standard 209B revision: an update (MDDI, Jun 1984, p. 41). Keywords: Cleanrooms, FS209.
1983
- Occupational exposure to ethylene oxide: the proposed rule (MDDI, Jul 1983, p. 31). Keywords: Et O, Standards, Occupational Safety.
- Current issues in the review of Federal Standard 209B, Robert D. Peck (MDDI, Jan 1983, p. 10). Keywords: Standards, FS209.
1982
- Implications of voluntary standards setting, Jim Phelps (MDDI, Aug 1982, p. 42). Keywords: Standards Setting, Standards.
