GB/T 11417.4-2012Ophthalmic optics -- Contact lenses -- Part 4: Saline solution for contact lens testing (English PDF)

Foreword

Ophthalmic optics - Contact lenses together with GB/T 28539 Ophthalmic optics -

Contact lenses and contact lens care products - Determination of preservative uptake

and release and GB/T 28538 Ophthalmic optics - Contact lenses and contact lenses

care products - Determination of biocompatibility by ocular study with rabbit eyes

constitute the national standard series for contact lenses.

Ophthalmic optics - Contact lenses is divided into the following 9 parts:

-- Part 1: Vocabulary, classification system and recommendations for labeling

specifications; (GB/T 11417.1)

-- Part 2: Rigid contact lenses specification; (GB 11417.2)

-- Part 3: Soft contact lenses; (GB 11417.3)

-- Part 4: Saline solution for contact lens testing; (GB/T 11417.4)

-- Part 5: Testing methods for optical properties; (GB/T 11417.5)

-- Part 6: Mechanical properties test methods; (GB/T 11417.6)

-- Part 7: Physicochemical properties test methods; (GB/T 11417.7)

-- Part 8: Determination of shelf-life; (GB/T 11417.8)

-- Part 9: Ageing by exposure to UV and visible radiation (in vitro method). (GB/T

11417.9)

This part is Part 4.

This part was drafted according to the rules given in GB/T 1.1-2009.

This part was compiled by using the redrafting method with reference to ISO 18369-

3:2006 Ophthalmic optics - Contact lenses - Part 3: Measurement methods and is not

equivalent to ISO 18369-3:2006.

1 Scope

GB/T 11417.4 gives the specification of a standard saline solution used in contact lens

testing.

This standard applies to standard saline solutions, which can be used as balanced

solutions for contact lenses or contact lens materials before testing, and can also be used

as immersion solutions during the testing process of certain items.

2 Normative references

The following documents are essential for the application of this document. For any

referenced document with a date, only the version corresponding to the date is

applicable to this document; for any undated referenced document, the latest version

(including all amendments) is applicable to this document.

GB/T 6682-2008 Water for analytical laboratory use - Specification and test

methods

GB/T 11417.1-2012 Ophthalmic optics - Contact lenses - Part 1: Vocabulary,

classification system and recommendations for labeling specifications

3 Terms and definitions

The terms and definitions defined in GB/T 11417.1-2012 apply to this document.

4 Requirements