Tässä kansainvälisessä standardissa määritellään piilolinssien, piilolinssien hoitotuotteiden ja muiden oheistuotteiden turvallisuutta ja suorituskykyä koskevat vaatimukset. Tässä kansainvälisessä standardissa ei määritellä sähköturvallisuutta ja sähkömagneettista yhteensopivuutta koskevia seikkoja, jotka voivat nousta esille kun sähkölaitteita käytetään yhdessä piilolinssien ja piilolinssien hoitotuotteiden kanssa.
Tämän julkaisun valmistelusta Suomessa vastaa Yhteinen Toimialaliitto, www.ytl.fi.
Sisällysluettelo
Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Safety and performance
5 Risk assessment
6 Design
7 Materials
8 Clinical evaluation
9 Manufacturing
10 Microbiological requirements
10.1 Contact lenses
10.2 Contact lens care products
10.3 Other accessories for contact lenses
11 Packaging
12 Shelf-life and discard date
13 Labelling and information supplied by the manufacturer
13.1 General
13.2 Additional information requirements for contact lenses
13.3 Additional information requirements for contact lens care products
ISO 10993-1:2009 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
ISO 11978:2014 Ophthalmic optics -- Contact lenses and contact lens care products -- Labelling
ISO 11980:2012 Ophthalmic optics -- Contact lenses and contact lens care products -- Guidance for clinical investigations
ISO 10993-1:2009 Biological evaluation of medical devices -- Part 1: Evaluation and testing within a risk management process
ISO 11978:2014 Ophthalmic optics -- Contact lenses and contact lens care products -- Labelling
ISO 11980:2012 Ophthalmic optics -- Contact lenses and contact lens care products -- Guidance for clinical investigations
ISO 11986:2010 Ophthalmic optics -- Contact lenses and contact lens care products -- Determination of preservative uptake and release
ISO 11987:2012 Ophthalmic optics -- Contact lenses -- Determination of shelf-life
ISO 13212:2014 Ophthalmic optics -- Contact lens care products -- Guidelines for determination of shelf-life
ISO 14155:2011 Clinical investigation of medical devices for human subjects -- Good clinical practice
ISO 14729:2001 Ophthalmic optics -- Contact lens care products -- Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses
ISO 14729:2001/Amd 1:2010
ISO 14730:2014 Ophthalmic optics -- Contact lens care products -- Antimicrobial preservative efficacy testing and guidance on determining discard date
ISO 14971:2007 Medical devices -- Application of risk management to medical devices
ISO 15223-1:2012 Medical devices -- Symbols to be used with medical device labels, labelling and information to be supplied -- Part 1: General requirements
ISO 18369-1:2006 Ophthalmic optics -- Contact lenses -- Part 1: Vocabulary, classification system and recommendations for labelling specifications
ISO 18369-2:2012 Ophthalmic optics -- Contact lenses -- Part 2: Tolerances
ISO 22442-1:2007 Medical devices utilizing animal tissues and their derivatives -- Part 1: Application of risk management
ISO 22442-2:2007 Medical devices utilizing animal tissues and their derivatives -- Part 2: Controls on sourcing, collection and handling
ISO 22442-3:2007 Medical devices utilizing animal tissues and their derivatives -- Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents