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Links to various industry and technical websites for reference purposes
NAFTA
How to submit a NAFTA request - View this document to understand the process for requesting NAFTA certification
NAFTA Request System
Standards Documents
AAMI (Association for the Advancement of Medical Instrumentation)
CEN (European Committee for Standardization)
FDA (Food and Drug Administration)
ISO (International Organization for Standardization)
Guidelines
PDA (Parenteral Drug Association)
AAMI, Association for the Advancement of Medical Instrumentation
3330 Washington Boulevard, Suite 400
Arlington, VA 22201-4598
Telephone: +1-703-525-4890
www.aami.org
These Standards have been recognized by the FDA (Food & Drug Administration), and are available on-line at:
www.aami.org/standards/standards.pubs.html#sterilization
- ANSI/AAMI ST 8:1994, Hospital Steam Sterilizers
- ANSI/AAMI ST 19:1994, Biological Indicators of Saturated Steam Sterilization Process in Health Care Facilities
- AMI ST 34:1991, Guideline for the Use of EO and Steam Biological Indicators in Industrial Sterilization Processes
- ANSI/AAMI ST 50: 1995, Dry Heat (Heated Air) Sterilizers
- ANSI/AAMI ST 55:1997, Table-Top Steam Sterilizers
- ANSI/AAMI/ISO 11134: 1993, Sterilization of Health Care Products-Requirements for Validation and Routine Control-Industrial Moist Heat Sterilization
- ANSI/AAMI/IS0 11135:1994, Medical Devices-Validation and Routine Control of EO Sterilization
- ANSI/AAMI/ISO 11135: 1994, Medical Devices-Validation and Routine Control of Ethylene Oxide Sterilization
CEN publications can be obtained in English from Customer Services, Sales Department at Chiswick, UK: Tel: 0181 996 7000; Fax: 0181 996 7001.
- EN 285, Descriptors: sterilization, medical equipment, sterilizers, water vapor, equipment specifications, locking devices, doors, fittings, measuring instruments, indicating instruments, specifications. CEN, European Committee for Standardization, Ref. No. prEN 285: 1996 E, Central Secretariat: rue de Stassart 36, B-1050 Brussels
- EN 550, Sterilization of medical devices - Validation and routine control of ethylene oxide sterilization. CEN, European Committee for Standardization, Ref. No. EN 550: 1994 E, Central Secretariat: rue de Stassart 36, B-1050 Brussels
- EN 554, Sterilization of medical devices - Validation and routine control of sterilization by moist heat. CEN, European Committee for Standardization, Ref. No. EN 554: 1994 E, Central Secretariat: rue de Stassart 36, B-1050 Brussels
- EN 556, Sterilization of medical devices - Requirements for medical devices to be labeled 'Sterile'. CEN, European Committee for Standardization, Ref. No. EN 556: 1994 E, Central Secretariat: rue de Stassart 36, B-1050 Brussels
- HMSO, NHS Estates, Health Technical Memorandum 2010, Part 3: Validation and verification. Sterilization. HMSO Publications Centre, PO Box 276, London SW8 5DT, UK
FDA publications can be obtained on-line at: www.fda.gov Click the following sequence: INDEX, C to F, Code of Federal Regulations. Under the "Browse Parts" column click the range of the parts you want.
- 21 CFR Part 11 Electronic Records; Electronic Signatures; Final Rule.
- 21 CFR Part 210 Current Good Manufacturing Practice in the Manufacture, Processing, Packing, or Holding of Drugs.
- 21 CFR Part 211 Current Good Manufacturing Practice for Finished Pharmaceuticals.
ISO International Standards Documents can be obtained from Global Engineering Documents at http://global.ihs.com
- ISO 10012-1: 1992 Quality assurance requirements for measuring equipment Part 1. Metrological confirmation system for measuring equipment
- ISO 10012 -1:1992 Quality assurance for measuring equipment Part 2: Guidelines for control of measurement processes
- ISO 11134 Sterilization of health care products - Requirements for validation and routine control - industrial moist heat sterilization.
- ISO 11138 -1:1994 Sterilization of health care products Biological indicators - Part 1: General
- ISO 11138 -2:1994 Sterilization of health care products Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization
- ISO 11138 - 3:1995 Sterilization of health care products Biological indicators Part 3: Biological indicators for moist heat sterilization
PDA publications can be obtained on-line at: www.pda.org
- Parenteral Drug Association, Validation of Steam Sterilization Cycles, Technical Monograph No. 1. Philadelphia, PA, 1978
- Parenteral Drug Association, Validation of Dry Heat Processes Used for Sterilization and Depyrogenation, Technical Report No 3. Philadelphia, PA, 1981
- Parenteral Drug Association, Parametric Release of Sterile Pharmaceuticals, Technical Report No 30. Bethesda, MD, May 3, 1999
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