BS EN ISO 16671 : 2015
Current
The latest, up-to-date edition.
OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY
Hardcopy , PDF
English
01-01-2015
Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Intended performance
5 Design attributes
6 Design evaluation
7 Sterilization
8 Product stability
9 Packaging
10 Information supplied by the manufacturer
Annex A (informative) - Example of a suitable
method for pH measurement and buffer
capacity determination
Annex B (normative) - Particulate contamination - Visible
particulates
Annex C (informative) - Light obscuration test method
for particulate contamination - sub-visible particles
Annex D (informative) - Microscopic test method for
particulate contamination - sub-visible particles
Annex E (normative) - Intraocular irrigation test
Annex F (informative) - Clinical investigation
Annex ZA (informative) - Relationship between
this European Standard and the Essential
Requirements of EU Directive 93/42/EEC
Bibliography
Specifies requirements with regards to safety for the intended performance, design attributes, preclinical and clinical evaluation, sterilization, product packaging, product labelling, and the information supplied by the manufacturer.
| Committee |
CH/172/7
|
| DevelopmentNote |
Supersedes 02/560790 DC. (12/2003) Supersedes 14/30295067 DC. (09/2015) Supersedes 17/30351468 DC. 2015 Edition Re-Issued in January 2018 & incorporates AMD 1 2017. (01/2018)
|
| DocumentType |
Standard
|
| Pages |
34
|
| PublisherName |
British Standards Institution
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| DIN EN ISO 16671:2015-12 | Identical |
| NBN EN ISO 16671 : 2015 | Identical |
| ISO 16671:2015 | Identical |
| I.S. EN ISO 16671:2015 | Identical |
| EN ISO 16671:2015 | Equivalent |
| NEN EN ISO 16671 : 2015 AMD 1 2017 | Identical |
| ONORM EN ISO 16671 : 2018 | Identical |
| NS EN ISO 16671 : 2015 AMD 1 2017 | Identical |
| NF EN ISO 16671 : 2015 AMD 1 2018 | Identical |
| UNE-EN ISO 16671:2016 | Identical |
| AAMI TIR19 : 1998 | GUIDANCE FOR ANSI/AAMI/ISO 10993-7: 1995, BIOLOGICAL EVALUATION OF MEDICAL DEVICES - PART 7: ETHYLENE OXIDE STERILIZATION RESIDUALS |
| EN ISO 10993-2:2006 | Biological evaluation of medical devices - Part 2: Animal welfare requirements (ISO 10993-2:2006) |
| EN ISO 13408-1:2015 | Aseptic processing of health care products - Part 1: General requirements (ISO 13408-1:2008, including Amd 1:2013) |
| ISO 10993-2:2006 | Biological evaluation of medical devices — Part 2: Animal welfare requirements |
| ISO 22442-1:2015 | Medical devices utilizing animal tissues and their derivatives — Part 1: Application of risk management |
| ISO 14630:2012 | Non-active surgical implants — General requirements |
| EN ISO 22442-1:2015 | Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2015) |
| EN 1041:2008+A1:2013 | Information supplied by the manufacturer of medical devices |
| ISO 13408-1:2008 | Aseptic processing of health care products — Part 1: General requirements |
| ISO 10993-7:2008 | Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals |
| ISO 10993-1:2009 | Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process |
| EN ISO 14971:2012 | Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01) |
| ISO 14155:2011 | Clinical investigation of medical devices for human subjects — Good clinical practice |
| ISO 14971:2007 | Medical devices — Application of risk management to medical devices |
| ISO 11607-1:2006 | Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| ISO 15223-1:2016 | Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements |
| ISO 10993-6:2016 | Biological evaluation of medical devices — Part 6: Tests for local effects after implantation |
| EN ISO 14630:2012 | Non-active surgical implants - General requirements (ISO 14630:2012) |
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