BS EN 868-1:1997
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
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Packaging materials and systems for medical devices which are to be sterilized General requirements and test methods
Hardcopy , PDF
26-10-2018
English
15-12-1997
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1 Scope
2 Normative references
3 Definitions
4 Requirements
5 Test methods
6 Documentation
7 Information
Annex A (informative) Guidance on clause 4
Annex B (informative) Microbial barrier evaluation scheme
Annex C (informative) Air impermeability - Test methods
Annex D (informative) Microbial barrier properties -
Test methods for materials
Annex E (informative) Microbial barrier properties -
Test methods for permeable closures (filter assembly,
tortuous path)
Annex F (informative) Impermeability and continuity of seals
formed by fusion or adhesion - Test methods
Annex G (informative) Impermeability of seals not formed by
fusion or adhesion - Test methods - Test procedure
for rigid containers
Annex H (informative) Bibliography
Annex ZA (informative) Clauses of this European Standard
addressing essential requirements or other provision
of EU Directives
Defines requirements and methods of test for packaging materials and systems for medical devices for terminal sterilization and for maintenance of sterility of the device.
| Committee |
CH/198
|
| DevelopmentNote |
Supersedes 92/58621 DC. (08/2005)
|
| DocumentType |
Standard
|
| Pages |
18
|
| PublisherName |
British Standards Institution
|
| Status |
Withdrawn
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| EN 868-1 : 1997 | Identical |
| UNI EN 868-1 : 1999 | Identical |
| DIN EN 868-1:1997-05 | Identical |
| I.S. EN 868-1:1997 | Identical |
| NBN EN 868-1 : 1997 | Identical |
| NS EN 868-1 : 1ED 1997 | Identical |
| UNE-EN 868-1:1997 | Identical |
| NEN EN 868-1 : 1997 | Identical |
| SN EN 868-1 : 1997 | Identical |
| NF EN 868-1 : 1997 | Identical |
| BS EN 866-1:1997 | Biological systems for testing sterilizers and sterilization processes General requirements |
| EN 556:1994 + A1:1998 | STERILIZATION OF MEDICAL DEVICES - REQUIREMENTS FOR TERMINALLY-STERILIZED MEDICAL DEVICES TO BE LABELLED "STERILE" |
| EN 550 : 1994 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF ETHYLENE OXIDE STERILIZATION |
| EN 285:2015 | Sterilization - Steam sterilizers - Large sterilizers |
| EN 46001 : 1996 | QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9001 |
| PREN 868-8 : DRAFT 2017 | 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 | Sterilization - Sterile supply - Part 6: Microbial barrier testing of packaging materials for medical devices which are to be sterilized |
| PREN 1422 : DRAFT 2011 | STERILIZERS FOR MEDICAL PURPOSES - ETHYLENE OXIDE STERILIZERS - REQUIREMENTS AND TEST METHODS |
| EN ISO 9002:1994/AC:1997 | QUALITY SYSTEMS - SPECIFICATION FOR PRODUCTION AND INSTALLATION |
| ISO 187:1990 | Paper, board and pulps — Standard atmosphere for conditioning and testing and procedure for monitoring the atmosphere and conditioning of samples |
| ISO 9002:1994 | Quality systems — Model for quality assurance in production, installation and servicing |
| PREN 868-5 : DRAFT 2017 | 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 | Paper and board — Determination of air permeance (medium range) — Part 2: Schopper method |
| ISO 5636-5:2013 | Paper and board — Determination of air permeance (medium range) — Part 5: Gurley method |
| EN 552:1994/A2:2000 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY IRRADIATION |
| ASTM F 1608 : 2016 : REDLINE | Standard Test Method for Microbial Ranking of Porous Packaging Materials (Exposure Chamber Method) |
| EN ISO 9001:2015 | Quality management systems - Requirements (ISO 9001:2015) |
| PREN 868-2 : DRAFT 2015 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 2: STERILIZATION WRAP - REQUIREMENTS AND TEST METHODS |
| EN 20187:1993 | 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 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 4: PAPER BAGS - REQUIREMENTS AND TEST METHODS |
| ISO 9001:2015 | Quality management systems — Requirements |
| EN 46002 : 1996 | QUALITY SYSTEMS - MEDICAL DEVICES - PARTICULAR REQUIREMENTS FOR THE APPLICATION OF EN ISO 9002 |
| ISO 11607:2003 | Packaging for terminally sterilized medical devices |
| BS 6255:1989 | Specification for plain sterilization paper for medical use |
| PREN 868-7 : DRAFT 2015 | 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 | 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 | PACKAGING FOR TERMINALLY STERILIZED MEDICAL DEVICES - PART 6: PAPER FOR LOW TEMPERATURE STERILIZATION PROCESSES - REQUIREMENTS AND TEST METHODS |
| EN 554 : 1994 | STERILIZATION OF MEDICAL DEVICES - VALIDATION AND ROUTINE CONTROL OF STERILIZATION BY MOIST HEAT |
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