DIN EN ISO 14534:2011
Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011); German version EN ISO 14534:2011

Standard No.

DIN EN ISO 14534:2011

Release Date

2011

Published By

German Institute for Standardization

Status

Be replaced

Replace By

DIN EN ISO 14534:2015

Latest

DIN EN ISO 14534:2015-08

Replace

DIN EN ISO 14534:2009

Scope

The International standard specifies safety and performance requirements for contact lenses, contact lens care products and other accessories for contact lenses. The International standard does not specify electrical safety and electromagnetic compatibility considerations that might arise from the use of electrical equipment in conjunction with contact lenses or contact lens care products.

DIN EN ISO 14534:2011 Referenced Document

• ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process*， 2018-08-01 Update
• ISO 11978 Ophthalmic optics — Contact lenses and contact lens care products — Labelling — Amendment 1*， 2020-10-07 Update
• ISO 11980 Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations*， 2012-11-01 Update
• ISO 11986 Ophthalmic optics - Contact lenses and contact lens care products - Determination of preservative uptake and release*， 2017-11-01 Update
• ISO 11987 Ophthalmic optics - Contact lenses - Determination of shelf-life*， 2012-07-01 Update
• ISO 13212 Ophthalmic optics - Contact lens care products - Guidelines for determination of shelf-life*， 2014-09-01 Update
• ISO 14155 Clinical investigation of medical devices for human subjects - Good clinical practice*， 2020-09-01 Update
• ISO 14730 Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date*， 2014-10-01 Update
• ISO 14971 Medical devices - Application of risk management to medical devices*， 2019-12-01 Update
• ISO 15223-1 Medical devices-Symbols to be used with information to be supplied by the manufacturer-Part 1: General requirements
• ISO 18369-1 Ophthalmic optics — Contact lenses — Part 1: Vocabulary, classification system and recommendations for labelling specifications*， 2017-08-23 Update
• ISO 18369-2 Ophthalmic optics — Contact lenses — Part 2: Tolerances*， 2017-08-23 Update
• ISO 22442 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

DIN EN ISO 14534:2011 history

• 2015 DIN EN ISO 14534:2015-08 Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011); German version EN ISO 14534:2015
• 2015 DIN EN ISO 14534:2015 Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011); German version EN ISO 14534:2015
• 2011 DIN EN ISO 14534:2011 Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011); German version EN ISO 14534:2011
• 2009 DIN EN ISO 14534:2009 Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2002); English version of DIN EN ISO 14534:2009-07