EN 556:1994 + A1:1998
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STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE" |
EN 550 : 1994
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STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION |
EN 285:2015
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Sterilization - Steam sterilizers - Large sterilizers |
EN 46001 : 1996
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QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9001 |
PREN 868-8 : DRAFT 2017
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PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 8: RE-USABLE STERILIZATION CONTAINERS FOR STEAM STERILIZERS CONFORMING TO EN 285 - REQUIREMENTS AND TEST METHODS |
DIN 58953-6:2016-12
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Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized |
PREN 1422 : DRAFT 2011
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STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS |
EN ISO 9002:1994/AC:1997
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QUALITY SYSTEMS - SPECIFICATION FOR PRODUCTION AND INSTALLATION |
ISO 187:1990
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Paper, board and pulps — Standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples |
ISO 9002:1994
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Quality systems — Model for quality assurance in production, installation and servicing |
PREN 868-5 : DRAFT 2017
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PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 5: SEALABLE POUCHES AND REELS OF POROUS MATERIALS AND PLASTIC FILM CONSTRUCTION - REQUIREMENTS AND TEST METHODS |
ISO 5636-2:1984
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Paper and board — Determination of air permeance (medium range) — Part 2: Schopper method |
ISO 5636-5:2013
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Paper and board — Determination of air permeance (medium range) — Part 5: Gurley method |
EN 552:1994/A2:2000
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STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION |
ASTM F 1608 : 2016 : REDLINE
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Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method) |
EN ISO 9001:2015
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Quality management systems - Requirements (ISO 9001:2015) |
PREN 868-2 : DRAFT 2015
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PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: STERILIZATION WRAP - REQUIREMENTS AND TEST METHODS |
EN 20187:1993
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Paper, board and pulps - Standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples (ISO 187:1990) |
PREN 868-4 : DRAFT 2015
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PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 4: PAPER BAGS - REQUIREMENTS AND TEST METHODS |
ISO 9001:2015
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Quality management systems — Requirements |
EN 46002 : 1996
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QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002 |
ISO 11607:2003
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Packaging for terminally sterilized medical devices |
BS 6255:1989
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Specification for plain sterilization paper for medical use |
PREN 868-7 : DRAFT 2015
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PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 7: ADHESIVE COATED PAPER FOR LOW TEMPERATURE STERILIZATION PROCESSES - REQUIREMENTS AND TEST METHODS |
PREN 868-3 : DRAFT 2015
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PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 3: PAPER FOR USE IN THE MANUFACTURE OF PAPER BAGS (SPECIFIED IN EN 868-4) AND IN THE MANUFACTURE OF POUCHES AND REELS (SPECIFIED IN EN 868-5) - REQUIREMENTS AND TEST METHODS |
PREN 868-6 : DRAFT 2015
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PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 6: PAPER FOR LOW TEMPERATURE STERILIZATION PROCESSES - REQUIREMENTS AND TEST METHODS |
EN 554 : 1994
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STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT |