GB/T 11417.4-2012 English PDF (GBT11417.4-2012)

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GB/T 11417.4-2012: Ophthalmic optics -- Contact lenses -- Part 4: Saline solution for contact lens testing
GB/T 11417.4-2012
GB
NATIONAL STANDARD OF THE
PEOPLE'S REPUBLIC OF CHINA
ICS 11.040.70
C 40
Ophthalmic optics - Contact lenses - Part 4: Saline solution
for contact lens testing
(ISO 18369-3:2006, Ophthalmic optics - Contact lenses - Part 3: Measurement
methods, NEQ)
ISSUED ON: DECEMBER 31, 2012
IMPLEMENTED ON: JUNE 1, 2013
Issued by: General Administration of Quality Supervision, Inspection and
Quarantine of PRC;
Standardization Administration of PRC.
Table of Contents
Foreword ... 3
1 Scope ... 5
2 Normative references ... 5
3 Terms and definitions ... 5
4 Requirements ... 5
5 Preparation procedure ... 6
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.
Please note that some of the contents of this document may involve patents. The issuing
organization of this document does not assume the responsibility for identifying these
patents.
This part is under the jurisdiction of the Technical Sub-committee on Medical Optics
and Instruments of the National Technical Committee on Optics and Photonics
Standardization Administration of China (SAC/TC103/SC1).
Ophthalmic optics - Contact lenses - Part 4: Saline solution
for contact lens testing
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
4.1 General
When this standard salt solution is used for testing, the test report shall indicate that a
standard salt solution that complies with this standard is used. If this standard salt
solution is not used, the results may vary and the composition of the solution used shall
be stated in the test report.
The standard salt solution shall be a phosphate buffer solution with a pH of 7.4±0.1 and