STANDARDISATION WORK OVERVIEW SINCE JANUARY 2005

1. Recently Published standards

ISO/CD 9342-2: Optics and optical instruments — Test lenses for calibration offocimeters — Part 2: Test lenses for focimeters used for measuring contact lenses.

This part of ISO 9342 specifies requirements for test lenses for the calibration of focimeters that are used for the measurement of contact lenses.

NOTE 1. It is accepted that other test lenses can also be used with powers within the given range, manufactured to the same standard of accuracy and form, but different back vertex powers.

This document was published as an ISO standard in November 2005

2. Corrections to existing standards

ISO 11981:1999/Cor.1:2005(E): Ophthalmic optics — Contact lenses and contact lens care products — Determination of physical compatibility of contact lens care products with contact lenses:

TECHNICAL CORRIGENDUM 1

Technical Corrigendum 1 to ISO 11981:1999 was prepared by Technical Committee ISO/TC 172, Optics and photonics, Subcommittee SC 7, Ophthalmic optics and instruments.

Pages 1 and 2, Clause 2

Replace the normative references such that they are undated and so that their most recent edition applies.

Delete footnotes 1) and 2).

Page 4, subclause 5.2

Add the following text after first paragraph.

“Taking into account recent reports on the incompatibility of certain silicones contained in hydrogels used systems for contact lenses. It is recommended that separate compatibility tests be performed on these types of materials with contact lens care systems.”

ISO 14730:2000 / Ophthalmic optics -- Contact lens care products -- Antimicrobial preservative efficacy testing and guidance on determining discard date : was systematically reviewed in 2005
ISO 11978:2000: Ophthalmic optics: Contact lenses and contact lens care products:
Information supplied by the manufacturer: was systematically reviewed in 2005.

3. Standards to be systematically reviewed in 2006

ISO 9340:1996 / Optics and optical instruments -- Contact lenses -- Determination of strains for rigid contact lenses
ISO 14730:2000 / Ophthalmic optics -- Contact lens care products -- Antimicrobial preservative efficacy testing and guidance on determining discard date

4.

Work in progress

Have reached the ISO/FDIS stage (registered for formal approval):

ISO/FDIS 18369-1: Ophthalmic optics -- Contact lenses -- Part 1: Terminology: expected to be voted before the end of April 2006.

ISO/FDIS 18369-2: Ophthalmic optics -- Contact lenses -- Part 2: Tolerances:

expected to be voted before the end of April 2006.

ISO/FDIS 18369-3: Ophthalmic optics -- Contact lenses -- Part 3: Measurement methods: expected to be voted before the end of April 2006.

ISO/FDIS 18369-4: Ophthalmic optics -- Contact lenses -- Part 4: Physicochemical properties of contact lens materials: expected to be voted before the end of April 2006.

ISO/WD 11980: Contact lenses and contact lens care products -- Guidance for clinical investigations : this WD (Working Document) has become a CD (Committee Document). The voting period ends March 27, 2006.

WD 18369-5 and WD 18369-6: Parts 5 and 6 of the Consolidated Contact Lens Standard are working documents and are up for voting to become full working drafts and/or sent out for voting as a New Work Item Proposal (NWIP).

5. NEW PROPOSALS

WORKING DRAFT ISO/WD 15752 :

Ophthalmic instruments — Endoilluminators — Fundamental requirements and test methods for optical radiation safety.

This International Standard specifies optical radiation safety aspects of endoilluminator light sources and endoilluminator light guides which are used to illuminate the interior of the eye during ocular surgery. This International Standard is not applicable to other active and non-active ophthalmic instruments and operation

microscopes.

New work item proposal ISO/TC 172/SC 7 N 764:

Ophthalmic Implants - Intraocular lenses – Accommodative Intraocular Lenses:

This standard applies to any ocular implant whose primary indication is the correction ofaphakia and is designed to provide vision over a continuous range of distances by affecting a change in the vergence power of the eye resulting from the implant design that changes eye optical power or implant position in response to a stimulus. For the purposes of this standard, these implants are referred to as accommodative intraocular lenses (AIOLs).

This standard addresses specific requirements for AIOLs that are not addressed in thenormative references, and include vocabulary, optical properties and test methods, mechanical properties and test methods, labelling, biocompatibility, sterility, shelf-life and transport stability, and clinical investigations necessary for this type of device. As with any standard, alternative validated test methods may be used.

NEW WORK ITEM PROPOSAL: ISO/TC 172 / SC 7 N 765

Ophthalmic Implants - Intraocular lenses - Toric Intraocular Lenses: Scope of proposed project:

Any monofocal IOL whose primary indication is the reduction of corneal astigmatismwith the correction of aphakia or the modification of the refractive power of thephakic eye. It does not include IOLs used to correct presbyopia. This standard addresses the vocabulary, optical properties and test methods, mechanical properties and test methods, labelling, biocompatibility, sterility, shelf-life and transport stability, and clinical investigations necessary for this type of device.

6. PUBLISHED STANDARDS APPLYING TO CONTACT LENSES, CONTACT LENS CARE PRODUCTS AND IOL’s. These standards can be obtained from the ISO website

ISO 8320-1:2003 / Contact lenses and contact lens care products -- Vocabulary -- Part 1: Contact lenses
ISO 8320-2:2001 / Contact lenses and contact lens care products -- Vocabulary -- Part 2: Contact lens care products
ISO 8321-1:2002 / Ophthalmic optics -- Specifications for material, optical and dimensional properties of contact lenses -- Part 1: Rigid corneal and scleral contact lenses
ISO 8321-2:2000 / Ophthalmic optics -- Specifications for material, optical and dimensional properties of contact lenses -- Part 2: Single-vision hydrogel contact lenses
ISO 8429:1986 / Optics and optical instruments -- Ophthalmology -- Graduated dial scale
ISO 8596:1994 / Ophthalmic optics -- Visual acuity testing -- Standard optotype and its presentation
ISO 8598:1996 / Optics and optical instruments -- Focimeters
ISO 8598:1996/Cor 1:1998
ISO 8599:1994 / Optics and optical instruments -- Contact lenses -- Determination of the spectral and luminous transmittance
ISO 8612:2001 / Ophthalmic instruments -- Tonometers
ISO 9337-1:1999 / Contact lenses -- Determination of back vertex power -- Part 1: Method using focimeter with manual focusing
ISO 9337-2:2004 / Contact lenses -- Determination of back vertex power -- Part 2: Measurement of contact lenses immersed in saline
ISO 9338:1996 / Optics and optical instruments -- Contact lenses -- Determination of the diameters
ISO 9339-1:1996 / Optics and optical instruments -- Contact lenses -- Determination of the thickness -- Part 1: Rigid contact lenses
ISO 9339-2:1998 / Optics and optical instruments -- Contact lenses -- Determination of thickness -- Part 2: Hydrogel contact lenses
ISO 9339-2:1998/Cor 1:2000
ISO 9340:1996 / Optics and optical instruments -- Contact lenses -- Determination of strains for rigid contact lenses
ISO 9341:1996 / Optics and optical instruments -- Contact lenses -- Determination of inclusions and surface imperfections for rigid contact lenses
ISO 9342-2:2005 / Optics and optical instruments -- Test lenses for calibration of focimeters -- Part 2: Test lenses for focimeters used for measuring contact lenses
ISO 9394:1998 / Ophthalmic optics -- Contact lenses and contact lens care products -- Determination of biocompatibility by ocular study using rabbit eyes
ISO 9801:1997 / Ophthalmic instruments -- Trial case lenses
ISO 9913-1:1996 / Optics and optical instruments -- Contact lenses -- Part 1: Determination of oxygen permeability and transmissibility with the FATT method
ISO 9913-2:2000 / Optics and optical instruments -- Contact lenses -- Part 2: Determination of oxygen permeability and transmissibility by the coulometric method
ISO 9914:1995 / Optics and optical instruments -- Contact lenses -- Determination of refractive index of contact lens materials
ISO 10338:1996 / Optics and optical instruments -- Contact lenses -- Determination of curvature
ISO 10339:1997 / Ophthalmic optics -- Contact lenses -- Determination of water content of hydrogel lenses
ISO 10340:1995 / Optics and optical instruments -- Contact lenses -- Method for determining the extractable substances
ISO 10341:1997 / Ophthalmic instruments -- Refractor heads
ISO 10342:2003 / Ophthalmic instruments -- Eye refractometers
ISO 10343:1997 / Ophthalmic instruments -- Ophthalmometers
ISO 10344:1996 / Optics and optical instruments -- Contact lenses -- Saline solution for contact lens testing
ISO 11978:2000 / Ophthalmic optics -- Contact lenses and contact lens care products -- Information supplied by the manufacturer
ISO 11979-1:1999 / Ophthalmic implants -- Intraocular lenses -- Part 1: Vocabulary
ISO 11979-2:1999 / Ophthalmic implants -- Intraocular lenses -- Part 2: Optical properties and test methods
ISO 11979-2:1999/Cor 1:2003
ISO 11979-3:1999 / Ophthalmic implants -- Intraocular lenses -- Part 3: Mechanical properties and test methods
ISO 11979-4:2000 / Ophthalmic implants -- Intraocular lenses -- Part 4: Labelling and information
ISO 11979-5:1999 / Ophthalmic implants -- Intraocular lenses -- Part 5: Biocompatibility
ISO 11979-6:2002 / Ophthalmic implants -- Intraocular lenses -- Part 6: Shelf-life and transport stability
ISO 11979-7:2001 / Ophthalmic implants -- Intraocular lenses -- Part 7: Clinical investigations
ISO 11979-8:1999 / Ophthalmic implants -- Intraocular lenses -- Part 8: Fundamental requirements
ISO 11979-8:1999/Cor 1:2003
ISO 11980:1997 / Ophthalmic optics -- Contact lenses and contact lens care products -- Guidance for clinical investigations
ISO 11980:1997/Cor 1:1998
ISO 11981:1999 / Ophthalmic optics -- Contact lenses and contact lens care products -- Determination of physical compatibility of contact lens care products with contact lenses
ISO 11981:1999/Cor 1:2005
ISO 11984:1999 / Ophthalmic optics -- Contact lenses -- Determination of rigid lens flexure and breakage
ISO 11985:1997 / Ophthalmic optics -- Contact lenses -- Ageing by exposure to UV and visible radiation (in vitro method)
ISO 11986:1999 / Ophthalmic optics -- Contact lenses and contact lens care products -- Guidelines for determination of preservative uptake and release
ISO 11987:1997 / Ophtalmic optics -- Contact lenses -- Determination of shelf-life
ISO 11987:1997/Cor 1:1998
ISO 12864:1997 / Ophthalmic optics -- Contact lenses -- Determination of scattered light
ISO 13212:1999 / Ophthalmic optics -- Contact lens care products -- Guidelines for determination of shelf-life
ISO 14534:2002 / Ophthalmic optics -- Contact lenses and contact lens care products -- Fundamental requirements
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 14730:2000 / Ophthalmic optics -- Contact lens care products -- Antimicrobial preservative efficacy testing and guidance on determining discard date
ISO 16671:2003 / Ophthalmic implants -- Irrigating solutions for ophthalmic surgery
ISO 16672:2003 / Ophthalmic implants -- Ocular endotamponades
ISO/TS 19979:2004 / Ophthalmic optics -- Contact lenses -- Hygienic management of multipatient use trial contact lenses
ISO 19980:2005 / Ophthalmic instruments -- Corneal topographers
ISO/TR 22979:2006 / Ophthalmic implants -- Intraocular lenses -- Guidance on assessment of the need for clinical investigation of intraocular lens design modifications