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GB 14724-2009Hard ocular prosthesis (English PDF)

硬质假眼

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Issued by

Standardization Administration of China

Level / Type

National · Mandatory

Issue date

September 30, 2009

Implementation date

November 1, 2009

Scope

GB 14724-2009 is the English-translated version of 硬质假眼.

GB 14724-2009 — This standard specifies the hard artificial eye terms, product classifications, technical requirements, test methods, inspection rules and signs, packaging, transportation and storage.

This standard applies to rigid polymer material false eye (hereinafter referred to as false eye).

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Document preview — GB 14724-2009

National Standard of the People's Republic of China

ICS: 11.040.70
Classification: C 45
Replacing: GB 14724-1993

Issued by: Standardization Administration of China

Foreword
1 Scope
2 Normative references
3 Terms and Definitions
4 Products
4.1 Varieties
4.2 Specifications
4.3 Model and meaning
4.4 Structure icon
5 Requirements
5.1 Health and Safety
5.2 Color
5.3 Appearance
5.4 Intensity artificial eye
6 Test methods
6.1 Health and Safety
6.2 Color
6.3 Appearance
6.4 Intensity artificial eye
7 Inspection rules
7.3 Factory inspection
7.4 Type inspection
8 Signs, packaging, transportation and storage
8.1 Mark
8.2 Packaging
8.3 Transport
8.4 Storage

Foreword

The standard Chapter 5, Chapter 6 and Chapter 7 are mandatory, the remaining chapters are recommended.

This standard replaces GB 14724-1993 "Hard false eye." this standard compared with GB 14724-1993 main changes are as follows.

a) Normative references, using GB/T 2828.1 "Sampling procedures for inspection - Part 1. by acceptance quality limit (AQL) inspection CABLE batch inspection sampling plan ", YY0270" dentistry denture base polymer ", YY/T 0268" Dentistry for oral Biocompatibility preclinical evaluation of medical devices cavity Module 1. Evaluation and testing project selection "and GB/T 16432" disability Classification and terminology aids people "instead of GB 2828" batch inspection Sampling procedures and sample forms (for continuous batch Check) ", GB 1710" pigment lightfastness Determination ", GB 8265" synthetic resin teeth "and GB 11417.1" hard corneal contact Contact lens ";

b) terms, modified thin artificial eye, artificial eye-shaped thick and special fake eye definitions of terms described increased Implantation Term Name Definition;

c) product category, product type and meaning an increase of the left and right to mark the location, design sequence number is deleted;

d) according to YY0270 "dentistry denture base polymer" requirements, and test methods for color stabilization has been modified;

e) in accordance with GB 11417.1 "hard contact lenses" Edit No. single request, removed the technical requirements of fake eye tensile strength;

f) in accordance with YY/T 0268 "Dentistry for preclinical evaluation of biocompatibility of medical devices oral first unit. Evaluation Select the pilot project "requirements, test methods for safety and health requirements have been modified;

g) prepared pursuant to the rules of product standards, remove the requirement to wear.

The standard proposed by the People's Republic of China Ministry of Civil Affairs.

This standard by the national rehabilitation and special equipment Standardization Technical Committee on Persons with Disabilities (SAC/TC148) centralized.

This standard was drafted. prosthetic Shanghai Co., Ltd., Shanghai China Technology Co., Ltd. Pok Hong multiplexing apparatus, the State Quality Supervision and rehabilitation equipment Inspection Center, Beijing orthopedic technology center in Sichuan physically disabled rehabilitation center.

1 Scope

This standard specifies the hard artificial eye terms, product classifications, technical requirements, test methods, inspection rules and signs, packaging, transportation and storage.

This standard applies to rigid polymer material false eye (hereinafter referred to as false eye).

2 Normative references

The following documents contain provisions which, through reference in this standard and become the standard terms. For dated references, subsequent Amendments (not including errata content) or revisions do not apply to this standard, however, encourage the parties to the agreement are based on research Whether the latest versions of these documents. For undated reference documents, the latest versions apply to this standard.

GB/T 191 Packaging - Pictorial signs (GB/T 191-2000, eqv ISO 780:1997) GB/T 2828.1 Sampling procedures for inspection - Part 1. by acceptance quality limit (AQL) retrieval batch inspection sampling plan (GB/T 2828.1-2003, ISO 2859-1:1999, IDT) GB/T 16432 Classification and terminology aids for disabled persons (GB/T 16432-2004, ISO 9999:2002, IDT) YY/T 0268 Dentistry Oral Biological evaluation of medical devices Module 1. Evaluation and testing (YY/T 0268-2008, neq ISO/FDIS7405.2008) YY0270-2003 dentistry denture base polymers (ISO 1567:1999, MOD)

3 Terms and Definitions

The following terms and definitions apply to this standard.

Imitation external appearance of the eye tissue prosthesis.

For enucleation, evisceration and post-atrophic eyeball cavity filled eyes, make up the artificial eye eye defects.

Note. references GB/T 16432063021 3.2 with a hard material, not deformed when wearing fake eye.

The equivalent of the cornea and the iris portion of the human eye.

Part of the body is equivalent to the sclera of the eye.

Equivalent to the human eye's pupil.

The human equivalent of the eye capillaries, red fibers arranged on the surface of the whites.

Press fake eye normal assembly position, the maximum size of the frontal plane in the horizontal direction.

Press fake eye normal assembly position, the maximum size of the frontal plane in the vertical direction.

It refers to the eye after enucleation or evisceration, or two while the ocular implantation muscle cone or sclera cavity to replace the missing eyes Volume, correct orbital depression.

3.10

Adaptation has been in the eye atrophy or ocular implantation in patients wearing fake eye.

3.11

Adaptation enucleation or evisceration patients wearing fake eye.

3.12

Adaptation has been in orbital implant implantation and drilling peg patient wearing fake eye.

4 Products

4.1 Varieties

Ocular prosthesis according to the thickness is divided into.

a) thin artificial eye, Pinyin letters "B" represents;

b) thick false eye shape, Pinyin letters "H" represents;

c) special fake eye, Pinyin letters "T" represents.

4.2 Specifications

Making false eye generally varies customization. When mass production, its size specifications are shown in Table 1.

Table 1 millimeters

Specifications major axis diameter minor black eye no. 1 no. 2 no. 3 20 to 23 23 to 26 26 to 30 17 to 20 20 to 22 22 ~ 25 9.5-10.5 10.5 to 11.5 11.5-12.5

4.3 Model and meaning

false eye code

species classification code Main parameters (long axis × short axis), mm Lateral position (on the left -L, right side -R) Model example.

On the left, the long axis of 24mm, 19mm short axis of thin fake eye; expressed as JYB-24 × 19L.

4.4 Structure icon

Structure shown in Figure 1.

Figure 1

5 Requirements

5.1 Health and Safety

5.1.1 Materials response nontoxic to humans and with human tissue and body fluids have good biocompatibility.

5.1.2 During normal wear, eyes and non-irritating to deal with pain, swelling and other unusual feeling human eye cavity tissue.

5.2 Color

After the press YY0270-2003 8.4 5.2.1 test, the color should be no significant change.

5.2.2 Distribution of color and bloodshot whites of the healthy eye should be similar for the two mounting eyes false eye color should be similar.

5.2.3 black eye, the pupil should be evenly colored, natural transition, no noise, and spots.

5.3 Appearance

5.3.1 transparent layer should be clean and bright, no bubbles, impurities, particle cracks.

5.3.2 edge transition should be smooth, no defects, edges, sharp corners.

5.3.3 shape, the proportion of each part of the healthy eye should be similar, consistent with the eye cavity.

5.4 Intensity artificial eye

False eye fall within 2m height not broken, do not crack.

6 Test methods

6.1 Health and Safety

Shall comply with YY/T 0268 in the corresponding material requirements.

6.2 Color

6.2.1 Press YY0270-2003 color stability in 8.4.

6.2.2 visually at 350lx ~ 380lx illuminance, compare false eye color difference with the healthy eye.

6.3 Appearance

In 350lx ~ 380lx illuminance, auxiliary of not less than five times the magnification observation equipment eye fake false eye shape and appearance quality, than the various parts Cases, the extent of the eye cavity anastomosis.

6.4 Intensity artificial eye

The fake eye from 2m height free drop cement floor three times.

7 Inspection rules

7.1 artificial eye is subject to factory inspection department inspection certificate and hang up before the factory.

7.2 Number of orders in the same batch.

7.3 Factory inspection

7.3.1 The sampling plan should be consistent with GB/T 2828.1.

7.3.2 custom products manufactured using the full inspection, the test items shown in Table 2, if there is a failure that is as unqualified products.

Table 2

Substandard classification test project technical requirements for inspection level AQL sampling plan type Color difference Transparent layer Smooth edge the proportion of each part shape 5.2.2, 5.2.3 5.3.1 5.3.2 5.3.3 C intensity 5.4 Once II 2.5 6.5

7.4 Type inspection

7.4.1 When one of the following conditions, type of inspection should be carried out.

a) identification of new products when styling;

b) false eye a significant change in the structure, processes, materials, time may affect the quality of products;

c) at least once every two years of normal production;

d) discontinued a year after the restoration of production;

e) national quality supervision department when requested.

7.4.2 Type test in the first batch of products in three randomly selected products as samples, according to Chapter 5, all items for inspection.

Type test if the health and safety indicators failed, then the product is substandard. Other If a failure can be in the original batch production Products in the doubling of the sampling, if still fail to meet the project, then the product is substandard.

8 Signs, packaging, transportation and storage

8.1 Mark

8.1.1 Package contents within the mark.

a) manufacturer's name and address;

b) the product name;

c) the trademark;

d) the date of manufacture or production lot;

e) type;

f) number.

8.1.2 packaging content of the flag.

a) the product name;

b) manufacturer's name and address;

c) number;

d) gross weight;

e) Handle with care, fear of wet, stacking layers limit sign by GB/T 191 requirements.

8.2 Packaging

8.2.1 Packaging materials should be stable, lined with soft materials.

8.2.2 Packaging accessories

a) Manual 1;

b) Certificate 1.

8.3 Transport

8.3.1 Transport should avoid severe vibration, bump and damp.

8.3.2 Transport process should avoid close to flammable and corrosive chemical and other harmful substances.

8.4 Storage

Store in a dry, cool, non-corrosive gas environments.

......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 7 pages — is available in the English PDF.

Referenced standards

Normative references

ISO 780 · ISO 2859 · ISO 9999 · ISO/FDIS7405.2008 · YY0270-2003 · ISO 1567

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