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Operation video of protective clothing sewing machine
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– NMPA guideline ,for technical review, of single-use surgical packs. 3. ,Product, standards for ,medical protective, equipment – GB19082-2009 ,Technical, Requirements for Single-use ,Protective Clothing, for ,Medical, Use – GB19083-2010 ,Technical, Requirements for ,Protective, Face Masks for ,Medical, Use – YY/T0969-2013 Single-use ,Medical, Face Mask
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Technical, Guide: ,Protective Clothing, and ,Medical, Devices Certification Manager: Graham Clements Page 2 of 6 Introduction Compliance of ,protective, garments with the ,Medical, Devices Directive 93/42/EEC or the Personal ,Protective, Equipment (PPE) Directive 89/686/EEC was originally a choice between the two when the Directives were first issued.
This practice also addresses putting label content on chemical ,protective clothing, packaging when it is not practical to attach the label directly to the chemical ,protective clothing, or print it on the chemical ,protective clothing, item based on the size or type of the ,product,. 1.2 This practice describes the recommended format and minimal content of the information to be included on the labels ...
2. According to the “Guiding Principles for the Technical Review of Medical Mask Product Registration” by the National Bureau, based on the intended use and scope of the product, it is generally divided into medical protective masks, medical surgical masks and disposable medical masks.
*Testing by an ISO 17025 certified third party laboratory is recommended. For more details, refer to ,technical, document “Considerations for Selecting ,Protective Clothing, used in Healthcare for ,Protection, Against Microorganisms in Blood and Body Fluids”, which provides a more detailed explanation of the scientific evidence and national and international standards, test methods, and ...
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Guidelines for ,Registration of Medical, Devices (revised April 12, 2006) Chapter 1 General ,Principles, Article 1 These Guidelines are formulated in accordance with the regulations of Article 40, Paragraph 3 of the Pharmaceutical Affairs Act (herein referred to as this Act).
Medicinal ,products, covered by the Drugs and Cosmetics Act (DCA) will not fall under Schedule M-III.  If there is any uncertainty about whether the ,product, falls under the drug or ,medical, device category of the DCA under this schedule, regulators will consider the principal mode of action of the ,product,.
The ,product technical, requirement for ,medical, device shall be compiled according to the China related national standard ,of medical product,. It is the most important document for ,product, safety and effectiveness evaluating and the appendix of the ,medical, device ,registration, certificate.CIRS offers normally used national & professional standards, and ,technical, requirements for your convenience.
the submission of the history of the ,medical, device marketed in the authorized country and a letter issued by the manufacturer of the MD to the importer in Argentina, granting the provision of Techno-vigilance data , adverse event reports, ,technical, claims, ,product, recall (if it has taken place) including data on corrective actions or changes that have been implemented.
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Protective clothing, should be worn in the following situations: ① When clinical medical personnel come into contact with patients with infectious diseases of Class A or Class A infectious diseases. ②When exposed to patients with infectious diseases spread by air or droplets, they may be splashed by blood, body fluids, secretions and excreta.