GB/T 37105-2018 English PDF

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GB/T 37105-2018: Packaging -- Braille on packaging for medicinal products
Status: Valid

Standard ID	USD	BUY PDF	Lead-Days	Standard Title (Description)	Status
GB/T 37105-2018	279	Add to Cart	3 days	Packaging -- Braille on packaging for medicinal products	Valid

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Basic data

Standard ID: GB/T 37105-2018 (GB/T37105-2018)
Description (Translated English): Packaging -- Braille on packaging for medicinal products
Sector / Industry: National Standard (Recommended)
Classification of Chinese Standard: C45
Classification of International Standard: 11.180
Word Count Estimation: 14,183
Date of Issue: 2018-12-28
Date of Implementation: 2019-07-01
Issuing agency(ies): State Administration for Market Regulation, China National Standardization Administration

GB/T 37105-2018: Packaging -- Braille on packaging for medicinal products

---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Packaging--Braille on packaging for medicinal products ICS 11.180 C45 National Standards of People's Republic of China Braille on packaged medicine packaging (ISO 17351.2013, MOD) Published on.2018-12-28 2019-07-01 implementation State market supervision and administration China National Standardization Administration issued

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. The main drafters of this standard. Li Mingjie, Ma Fengling, Li Qingzhong, Shi Xiaoyan, Zou Hua, and Xin Xin. Braille on packaged medicine packaging

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 article. Pieces. 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

4.1 Product Identification 4.1.1 Braille information The Braille text specified on the label should include Braille information as specified by the State. The labeling of drugs and the addition of Braille in the market in this standard should comply with the relevant regulations (see Appendix C). Note. In order to accommodate legally required information, ensure that the point does not include any printed text and that it contains no more than one set of Braille text. ......

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