GB/T 37105-2018Packaging -- Braille on packaging for medicinal products (English PDF)

Foreword

This standard was drafted in accordance with the rules given in GB/T 1.1-2009.

This standard uses the redrafting method to modify the use of ISO 17351.2013 "Braille on packaged pharmaceutical packaging."

This standard has more structural adjustments than ISO 17351.2013. This standard and ISO 17351.2013 are listed in Appendix A.

The chapter number is compared to the list.

There are technical differences between this standard and ISO 17351.2013, and the terms involved in these differences have been passed on the outer margins of the margins.

The vertical line (|) is marked, and a list of the corresponding technical differences and their causes is given in Appendix B.

This standard was proposed by the Ministry of Civil Affairs of the People's Republic of China

This standard is under the jurisdiction of the National Technical Committee for the Standardization of Rehabilitation and Special Equipment for Persons with Disabilities (SAC/TC148).

This standard was drafted. National Rehabilitation Aids Research Center, China Blind Association, China Braille Press.

1 Scope

This standard specifies the requirements and guidelines for the use of Braille on drug labels.

This standard applies to Braille on drug labels.

Note. The principles of this standard may be applied to other departments as appropriate.

2 Normative references

The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this document. For undated references, the latest edition (including all amendments) applies to this document.

GB/T 15720 Chinese Braille

3 Terms and definitions

The following terms and definitions apply to this document.

3.1

Braille braile

With six bumps as the basic structure, the words are arranged according to certain rules and touched by touch.

3.2

Square brailecel

The rectangular position occupied by a blind character.

3.3

Burst burst-through

Cracking, destruction, pinholes on the surface of the coating or material visible to the naked eye caused by the braille process.

3.4

Labeling

Information on the inner or outer packaging.

3.5

Listing license holder marketingauthorizationholder; MAH

A natural person, legal person, or entity that puts a drug on the market.

4 General requirements for pharmaceutical packaging