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Medical Device Quality Requirements
Sterilization
Packaging
Quality Systems
Cleaning/Passivation
Labeling
Environmental
Sterilization
AAMI ST72: 2002
Bacterial endotoxin-Test methodologies, routine monitoring and alternatives to batch testing
AAMI TIR16: 2000
Process development and performance qualification for ethylene oxide sterilization - Microbiological aspects
AAMI TIR28: 2009
Product adoption and process equivalence for ethylene oxide sterilization
AAMI TIR 33: 2005
Sterilization of health care products - Radiation sterilization - Substantiation of a selected sterilization dose - Method VDmax
ISO 10993-7:2008
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals
ISO 11135-1: 2007
Sterilization of health care products - Ethylene oxide - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 11137-1: 2006
Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
ISO 11137-2: 2006
Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose
ISO 11137-3: 2006
Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects
ISO 11138-1: 2006
Sterilization of health care products - Biological indicators - Part 1: General requirements
ISO 11138-2: 2006
Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes
ISO 11737-1: 2006
Sterilization of medical devices - Microbiological methods - Part 1: Determination of a population of microorganisms on products
ISO 11737-2: 2009
Sterilization of medical devices - Microbiological methods - Part 2: Tests of sterility performed in the validation of a sterilization process
ISO 17665-1: 2006
Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
Packaging
ASTM D3078-02
Standard Method for Determination of Leaks in Flexible Packaging by Bubble Emission
ASTM D4169-09
Standard Practice for Performance Testing of Shipping Containers and Systems
ASTM F88-09
Standard Test Method for Seal Strength of Flexible Barriers Materials
ASTM F1140-07
Standard Test Method for Internal Pressurization Failure Resistance of Unrestrained Packages for Medical Applications
ASTM F1608-00
Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method)
ASTM F1886-09
Standard Test Method for Determining Integrity of Seals for Medical Packaging by Visual Inspection
ASTM F1929-98
Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
ASTM F1980-07
Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices
ASTM F2096-04
Standard Test Method for Detecting Leaks in Medical Packaging by Internal Pressurization (Bubble Test)
DuPont Medical Packaging
Technical Reference Guide, 2009
DuPont Tyvek Compliance
Compliance to ISO 11607-1:2006, K-16972, 2007
ISO 11607-1: 2006
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging
ISO 11607-2: 2006
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes
ISTA 3A 2008
Packaged-Products for Parcel Delivery System Shipment 70 kg (150 lb) or Less
Quality Systems
AAMI TIR36: 2007
Validation of software for regulated processes
ANSI Z1.9-2008 (ASQC)
Sampling Procedures and Tables for Inspection by Variables for Percent Nonconforming
ANSI Z1.4-2008 (ASQC)
Sampling Procedures and Tables for Inspection by Attributes
FDA 21 CFR 210 and 211
cGMP Practice in Manufacturing, Processing, Packing or Holding of Drugs; Practice for Finished Pharmaceuticals, 4/1/2009
FDA 21 CFR 820
Quality System Regulation (GMP for Medical Devices), 4/1/2009
ISO 13485: 2003
Medical devices - Quality management systems - Requirements for regulatory purposes
ISO 14971: 2007
Medical devices - Application of risk management to medical devices
ISO 9001: 2008
Quality management systems – Requirements
OSHA 29 CFR 1910
Blood borne Pathogens, 2008
Cleaning/Passivation
ASTM A380-06
Standard Practice for Cleaning, Descaling, and Passsivation of Stainless Steel Parts, Equipment, and Systems
ASTM A967-05
Standard Specification for Chemical Passivation Treatments for Stainless Steel Parts
ASTM B600-91
Standard Guide for Descaling and Cleaning Titanium Alloy Surfaces
ASTM F2459-05
Standard Test Method for Extracting Residue from Metallic Medical components and Quantifying via Gravimetric analysis
ISO 10993-5: 2009
Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity
Labeling
EN 980:2008
Graphical Symbols for Use in the Labeling of Medical Devices
FDA 21 CFR Part 801
Medical Devices: Labeling, 4/1/2009
ISO 15223-1:2007
Medical devices - Symbols to be used with medical device labels, labeling, and information to be supplied - Part 1: General requirements
Environmental
ISO 14644-1: 1999
Cleanrooms and associated controlled environments - Part 1: Classification of air cleanliness
ISO 14644-2: 2000
Cleanrooms and associated controlled environments - Part 2: Specifications for testing and monitoring to prove continued compliance with ISO 14644-1
ISO 14698-2: 2003
Cleanrooms and associated controlled environments -- Biocontamination control -- Part 2: Evaluation and interpretation of biocontamination data
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