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Disposable medical face mask standard. It is required to cover the mouth, nose, and jaw. It prevents the user from exhaling pollutants from the mouth and nose. This standard of face mask is applicable in the general medical environment.

How to differentiate Made in China “Disposable Mask” available in Malaysia market.

According to the definition of the "Standardization Law of the People's Republic of China": disposable mask standards include National standards, Industry standards, Group standards.

Standard requirement ranking from high to low : National standards → Industry standards → Group standards. Below are common standards of Made in China disposable mask available in the market through Authentic reseller (: Due diligence is still strongly suggested to perform on the source of company and certification)

1. National standard       - GB/T 32610-2016

2. Industry standard       - YY/T 0969-2013

3. Group standards  - T/CTA 7-2019

 

 During this Coronavirus Pandemic, Chinese Covid-19 expert Zhong Nanshan (钟南山) strongly suggested to use 

YY/T 0969-2013 as daily disposable mask.

1. National Standards - National standards refer to standards that are adopted and publicly released by national agencies.

The compulsory national standards are technical requirements for guaranteeing personal health, life and property safety, national safety, ecological environment safety, and meeting the basic needs of economic and social management. Recommended national standards are technical requirements to meet the needs of basic universality, matching with mandatory national standards, and leading the relevant industries.

Mandatory national standard code: GB

Recommended national standard code: GB/T

GB is the Chinese Pinyin abbreviation of "National Standard", "T" is the recommended meaning

"Civil protective mask standard GB/T 32610-2016 refer to Daily protective mask technical specifications, GB 2626-2006 refer to respiratory protective equipment self-priming filter anti-particulate respirator, mainly for particulate protection, in this Coronavirus prevention Control plays an important role."

Excerpt from http://www.gov.cn/xinwen/2020-03/24/content_5494791.htm

2. Industry Standards - Industry standards refer to technical requirements that do not have recommended national standards and need to be unified within the industry across the country.

The industry standard is a supplement to the national standard and is a unified standard in the industry across the country. The industry standards shall be abolished on their own after the implementation of the corresponding national standards. At present, the standardization administrative department of the State Council has approved the issuance of standard codes for 67 industries. In the past, there were also mandatory and recommended standards for industry standards. In the latest version of the Standardization Law that came into effect on January 1, 2018, mandatory industry standards have been removed.

The recommended industry standard for medical devices: YY/T

YY is the Chinese pinyin abbreviation of "medicine".

"At present, Chinese mask standards mainly regulate civil protection and medical protection. The medical field standards GB 19083-2010 "Technical Requirements for Medical Protective Masks", YY 0469-2011 "Medical-Surgical Masks", YY/T 0969-2013 "Disposable medical masks" is mainly applicable to medical institutions."

Excerpt from http://www.gov.cn/xinwen/2020-03/24/content_5494791.htm

3. Group standards - Group standards are standards that are independently formulated and published by the group in accordance with the standard-setting procedures established by the group and are adopted voluntarily by society. Social groups can formulate group standards in the absence of national standards, industry standards, and local standards to quickly respond to innovation and market demand for standards, and existing standards are blank. The state encourages social groups to formulate group standards that are stricter than national and industry standards, to lead the development of industries and enterprises, and to enhance the market competitiveness of products and services. The group standard number is composed of the group standard code (T), the social group code, the group standard sequence number, and the year number in turn. The social group code in the group standard number should be legal and unique, and should not overlap with the existing standard code, and should not overlap with the existing social group code on the national group standard information platform.


按照《中华人民共和国标准化法》的定义:一次性口罩标准包括国家标准、行业标准、团体标准,企业标准。目前马来西亚市场上出现的中国制造一次性口罩的标准,通常情况下我们选用标准时的顺序为:国标→行标→团标

  1. 国家标准 – GB/T 32610-2016
  2. 行业标准 – YY/T 0969-2013
  3. 团体标准 – T/CTA 7-2019

在这次冠状病毒大流行期间,中国新冠病毒专家钟南山院士强烈建议使用

YY / T 0969-2013作为日常一次性口罩。

  1. 国家标准 - 国家标准是指由国家机构通过并公开发布的标准。

强制性国家标准是对保障人身健康和生命财产安全、国家安全、生态环境安全以及满足经济社会管理基本需要的技术要求。推荐性国家标准是对满足基础通用、与强制性国家标准配套、对各有关行业起引领作用等需要的技术要求。

强制性国家标准代号:GB

推荐性国家标准代号:GB/T

GB即"国标"的汉语拼音缩写,"T"是推荐的意思

“民用防护型口罩标准GB/T 32610—2016《日常防护型口罩技术规范》、GB 2626—2006《呼吸防护用品自吸过滤式防颗粒物呼吸器》,主要适用于颗粒物防护,在此次疫情防控中发挥了重要作用。”

摘自 http://www.gov.cn/xinwen/2020-03/24/content_5494791.htm

  1. 行业标准 - 行业标准是指没有推荐性国家标准、需要在全国某个行业范围内统一的技术要求。

行业标准是对国家标准的补充,是在全国范围的某一行业内统一的标准。行业标准在相应国家标准实施后,应自行废止。目前,国务院标准化行政主管部门已批准发布了67个行业的标准代号。过去行业标准也有强制性标准与推荐性标准之分,在2018年1月1日生效的最新版标准化法中已经去除了强制性行业标准。

医疗器械推荐性行业标准:YY/T

YY 即"医药"的汉语拼音缩写。

“目前,中国口罩标准主要规范民用防护和医用防护两大领域。医用领域标准GB 19083—2010《医用防护口罩技术要求》、YY 0469—2011《医用外科口罩》、YY/T 0969—2013《一次性使用医用口罩》,主要适用于医疗机构。” 摘自 http://www.gov.cn/xinwen/2020-03/24/content_5494791.htm

  1. 团体标准

团体标准是由团体按照团体确立的标准制定程序自主制定发布,由社会自愿采用的标准。社会团体可在没有国家标准、行业标准和地方标准的情况下,制定团体标准,快速响应创新和市场对标准的需求,现有标准空白。国家鼓励社会团体制定严于国家标准和行业标准的团体标准,引领产业和企业的发展,提升产品和服务的市场竞争力。团体标准编号依次由团体标准代号(T)、社会团体代号、团体标准顺序号和年代号组成。团体标准编号中的社会团体代号应合法且唯一,不应与现有标准代号相重复,且不应与全国团体标准信息平台上已有的社会团体代号相重复。团体标准代号:T

“T/CTCA 7-2019标准适用于在日常生活中滤除花粉、柳絮、细菌颗粒物和阻隔鼻腔或口腔呼出或喷出污染物所佩 戴的防护型口罩。”

摘自  https://www.p-oled.cn/wp-content/uploads/2020/04/TCTCA-7-2019一次性使用口罩.pdf

 

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