British Standards Institution

Sector: Governance & Resilience

Categories: Medical equipment | Health care technology | Medical equipment. Ophthalmic

Overview: Is responsible for appointing members to ISO/TC 172/SC 7/WG 9 and relevant CEN/TC 170 working groups; briefing UK delegates ahead of European and international meetings and to determine the UK response to documents that are being developed. Membership can be nominated by Government, Academic Facilities, Trade Associations etc. For further information on the committee please contact the Committee Secretary.

Committee standards activity

In Progress (7)

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Reference	Standards description	Status ? The standards development process is divided into chronological stages: Proposal; Drafting; Public comment; Comment resolution; Approval; Published standard.
PD ISO/TS 24891	Ophthalmic optics — Contact lenses and contact lens care products — Proposed symbols for use with contact lenses and lens care products Categories: Unclassified documents Drafting begins : 2025-03-31	Drafting
BS ISO 19045-3	Ophthalmic optics — Contact lens care products — Part 3: Part 3: Method for evaluating disinfecting efficacy by contact lens care products using cysts of Acanthamoeba species as the challenge organisms Categories: Unclassified documents Proposal begins :	Proposal
BS EN ISO 18369-1	Ophthalmic optics — Contact lenses — Part 1: Vocabulary, classification system and recommendations for labelling specifications Categories: Health care technology \| Medical equipment. Ophthalmic Public comment begins : 2025-05-15	Public comment
BS EN ISO 14729:2001/Amd 2	Ophthalmic optics — Contact lens care products — Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses - Amendment 2: Ophthalmic optics — Contact lens care products — Microbiological require Categories: Unclassified documents Drafting begins : 2025-01-14	Drafting
BS EN ISO 11987	ISO 11987 Ophthalmic optics. Contact lenses. Determination of shelf-life Categories: Medical equipment. Ophthalmic Public comment begins : 2025-05-01	Public comment
BS EN ISO 11986	ISO 11986 Ophthalmic optics. Contact lenses and contact lens care products. Determination of preservative uptake and release Categories: Medical equipment. Ophthalmic Public comment begins : 2025-05-01	Public comment
BS EN ISO 11980	Ophthalmic optics — Contact lenses and contact lens care products — Requirements and guidance for clinical investigations Categories: Medical equipment. Ophthalmic Approval begins : 2025-07-03	Approval

Published (15)

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Reference	Standards description	Status ? The standards development process is divided into chronological stages: Proposal; Drafting; Public comment; Comment resolution; Approval; Published standard.
PD ISO/TS 6838:2024	Ophthalmic optics — Contact lenses — Tolerances and methods for measurement of multifocal contact lens addition power Categories: Medical equipment. Ophthalmic Published standard begins : 2024-07-17	Published standard
BS ISO 19045:2015	Ophthalmic optics. Contact lens care products. Method for evaluating Acanthamoeba encystment by contact lens care products Categories: Medical equipment. Ophthalmic Published standard begins : 2015-04-23	Published standard
BS ISO 19045-2:2024	Ophthalmic optics. Contact lens care products. Method for evaluating disinfecting efficacy by contact lens care products using trophozoites of Acanthamoeba species as the challenge organisms Categories: Medical equipment. Ophthalmic Published standard begins : 2024-12-06	Published standard
BS ISO 18259:2014	Ophthalmic optics. Contact lens care products. Method to assess contact lens care products with contact lenses in a lens case, challenged with bacterial and fungal organisms Categories: Medical equipment. Ophthalmic Published standard begins : 2014-09-30	Published standard
BS ISO 18189:2016	Ophthalmic optics. Contact lenses and contact lens care products. Cytotoxicity testing of contact lenses in combination with lens care solution to evaluate lens/solution interactions Categories: Medical equipment. Ophthalmic Published standard begins : 2016-06-09	Published standard
BS EN ISO 9394:2012	Ophthalmic optics. Contact lenses and contact lens care products. Determination of biocompatibility by ocular study with rabbit eyes Categories: Medical equipment. Ophthalmic Published standard begins : 2012-10-16	Published standard
BS EN ISO 18369-2:2017	Ophthalmic optics. Contact lenses. Tolerances Categories: Health care technology \| Medical equipment. Ophthalmic Published standard begins : 2017-09-29	Published standard
BS EN ISO 14730:2014	Ophthalmic optics. Contact lens care products. Antimicrobial preservative efficacy testing and guidance on determining discard date Categories: Medical equipment. Ophthalmic Published standard begins : 2014-10-20	Published standard
BS EN ISO 14729:2001+A1:2010, BS 7208-26:2001	Ophthalmic optics. Contact lens care products. Microbiological requirements and test methods for products and regimens for hygienic management of contact lenses Categories: Medical equipment. Ophthalmic Published standard begins : 2011-01-06	Published standard
BS EN ISO 14534:2015	Ophthalmic optics. Contact lenses and contact lens care products. Fundamental requirements Categories: Medical equipment. Ophthalmic Published standard begins : 2015-02-04	Published standard

Withdrawn (33)

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Reference	Standards description	Status ? The standards development process is divided into chronological stages: Proposal; Drafting; Public comment; Comment resolution; Approval; Published standard.
PD ISO/TS 19979:2014	Ophthalmic optics. Contact lenses. Hygienic management of multipatient use trial contact lenses Categories: Medical equipment. Ophthalmic Withdrawn begins : 2018-03-21	Withdrawn
DD ISO/TS 19979:2004	Ophthalmic optics. Contact lenses. Hygienic management of multipatient use trial contact lenses Categories: Medical equipment. Ophthalmic Withdrawn begins : 2015-02-02	Withdrawn
BS ISO 19979:2018	Ophthalmic optics. Contact lenses. Hygienic management of multipatient use trial contact lenses Categories: Medical equipment. Ophthalmic Withdrawn begins : 2023-06-13	Withdrawn
BS EN ISO 9913-2:2000, BS 7208-23:2000	Optics and optical instruments. Contact lenses. Determination of oxygen permeability and transmissibility by the coulometric method Categories: Medical equipment. Ophthalmic Withdrawn begins : 2006-09-20	Withdrawn
BS EN ISO 9337-2:2004	Contact lenses. Determination of back vertex power. Measurement of contact lenses immersed in saline Categories: Medical equipment. Ophthalmic Withdrawn begins : 2006-10-03	Withdrawn
BS EN ISO 8321-2:2000, BS 7208-24:2000	Optics and optical instruments. Contact lenses. Single-vision hydrogel contact lenses Categories: Medical equipment. Ophthalmic Withdrawn begins : 2006-10-31	Withdrawn
BS EN ISO 8320-2:2001, BS 7208-19:2001	Contact lenses and contact lens care products. Vocabulary. Contact lens care products Categories: Health care technology \| Medical equipment. Ophthalmic Withdrawn begins : 2006-10-31	Withdrawn
BS EN ISO 18369-4:2017	Ophthalmic optics. Contact lenses. Physicochemical properties of contact lens materials Categories: Medical equipment. Ophthalmic Withdrawn begins : 2018-04-06	Withdrawn
BS EN ISO 18369-4:2006	Ophthalmic optics. Contact lenses. Physicochemical properties of contact lens materials Categories: Medical equipment. Ophthalmic Withdrawn begins : 2017-10-09	Withdrawn
BS EN ISO 18369-3:2017	Ophthalmic optics. Contact lenses. Measurement methods Categories: Medical equipment. Ophthalmic Withdrawn begins : 2018-04-06	Withdrawn

Standards Development

CH/172/9 - Contact lenses and contact lens care products

Committee standards activity