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GB 27951-2021General requirements for skin disinfectant (English PDF)

皮肤消毒剂通用要求

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Issued by

State Administration for Market Regulation; Standardization Administration of China

Level / Type

National · Mandatory

Issue date

October 11, 2021

Implementation date

November 1, 2022

Scope

GB 27951-2021 is the English-translated version of 皮肤消毒剂通用要求.

GB 27951-2021 specifies the raw material requirements, technical requirements, test methods, method of use and marking of skin disinfectants, and applies to disinfectants used on intact and damaged skin.

Active ingredients must meet the hygienic standards for their class (guanidines, iodine, quaternary ammonium compounds, peroxides, alcohols, phenols, acidic electrolyzed water, hypochlorous acid), with excipients and production water to Pharmacopoeia requirements.

Technical requirements cover a shelf life of at least 12 months, microbial contamination limits of 10 CFU/mL (g) for bacteria and for moulds and yeasts with no pathogenic pyogenic bacteria (sterile products for damaged skin), log reductions of at least 5.00 (suspension) and 3.00 (carrier) against Staphylococcus aureus and Pseudomonas aeruginosa and 4.00 and 3.00 against Candida albicans within 5.0 min, toxicological tests to WS 628, limits of 10 mg/L lead, 1 mg/L mercury and 2 mg/L arsenic, and a ban on antibiotics, antifungal and antiviral drugs and hormones; normative Annex A gives the microbial contamination test methods.

It replaces GB 27951-2011, adding raw material requirements, a multiple skin irritation test and tests for prohibited drugs, revising the definition of intact skin and deleting the sensory indicators, the acute eye irritation and skin sensitization tests.

It was issued on 11 October 2021 and has been in force since 1 November 2022. Classification: ICS 11.080, CCS C50. The document runs to 12 pages, delivered complete in English translation.

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Document preview — GB 27951-2021

National Standard of the People's Republic of China

ICS: 11.080
Classification: C50
Replacing: GB 27951-2011

Issued by: State Administration for Market Regulation; Standardization Administration of China

Foreword
1 Scope
2 Normative references
3 Terms and definitions
4 Requirements on the raw materials
5 Technical requirements
6 Inspection methods
7 Method of use
8 Marking
Annex A (normative) Method for the inspection of the microbiological contamination indexes
Annex B (informative) Recommended doses and methods of use of the commonly used skin disinfectants

3 Terms and definitions

4 Requirements on the raw materials

5 Technical requirements

6 Inspection methods

7 Method of use

8 Marking

Foreword

This document was drafted in accordance with the rules given in GB/T 1.1-2020 Directives for standardization - Part 1: Rules for the structure and drafting of standardizing documents.

This document replaces GB 27951-2011 Hygienic requirements for skin disinfectant. Compared with GB 27951-2011, apart from structural adjustments and editorial changes, the main technical changes are as follows:

- some normative references have been added and deleted (see Chapter 2; Chapter 2 of the 2011 edition);

- the definition of intact skin has been changed (see 3.3);

- raw material requirements have been added (see Chapter 4);

- the types of disinfectant commonly used for intact skin and damaged skin have been deleted (see 4.1.1 and 4.1.2 of the 2011 edition);

- the sensory indicators have been deleted (see 4.3.1 of the 2011 edition);

- the product quality requirements have been revised as technical requirements (see Chapter 5);

- the multiple skin irritation test has been added to Table 2 of the toxicological indicators, and the acute eye irritation test and the skin sensitization test have been deleted from Table 2 (see 5.3.1; 4.3.4 of the 2011 edition);

- the position of restricted substances and prohibited substances in the standard has been adjusted (see 5.3.2, 5.3.3 and 8.2);

- requirements for the determination of antibiotics, antifungal drugs, antiviral drugs, etc. have been added (see 6.3.3);

- labels and instructions for use and precautions have been merged into marking (see Chapter 8).

Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. The issuing body of this document shall not be held responsible for identifying any or all such patent rights.

This document was proposed by and is under the jurisdiction of the National Health Commission of the People's Republic of China.

The previous editions of this document and of the document it replaces are as follows:

- first published in 2011 as GB 27951-2011;

- this is the first revision.

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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 12 pages — is available in the English PDF.

Referenced standards

Normative references

Cited by

Similar standards

GB 19193-2015|GB 27948-2020|GB 27949-2020|GB 27950-2020|GB 27952-2020

Editions of GB 27951

Edition	Title	Revision	Status
GB 27951-2021	General requirements for skin disinfectant	current edition	Current
GB 27951-2011	Hygiene requirements for skin disinfectant	previous edition	Superseded

This page sells the current edition, GB 27951-2021. Earlier editions are listed for reference only.

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