I.S. EN ISO 16671:2015
Superseded
A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
View Superseded by
OPHTHALMIC IMPLANTS - IRRIGATING SOLUTIONS FOR OPHTHALMIC SURGERY (ISO 16671:2015)
Hardcopy , PDF
10-07-2020
English
01-01-2015
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Only cited Standards give presumption of conformance to New Approach Directives/Regulations.
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National Foreword
European foreword
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
Bibliography
Annex ZA (informative) - Relationship between this European
Standard and the Essential Requirements of EU Directive
93/42/EEC
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.
| DocumentType |
Standard
|
| Pages |
40
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Superseded
|
| SupersededBy | |
| Supersedes |
| Standards | Relationship |
| BS EN ISO 16671 : 2015 | Identical |
| DIN EN ISO 16671:2015-12 | Identical |
| NBN EN ISO 16671 : 2015 | Identical |
| UNE-EN ISO 16671:2016 | Identical |
| ISO 16671:2015 | Identical |
| UNI EN ISO 16671 : 2004 | Identical |
| SN EN ISO 16671 : 2016 AMD 1 2018 | Identical |
| 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 |
| 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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