Shanghai Sunland Industrial Co., Ltd is the top manufacturer of Personal Protect Equipment in China, with 20 years’experience. We are the Chinese government appointed manufacturer for government power,personal protection equipment , medical instruments,construction industry, etc. All the products get the CE, ANSI and related Industry Certificates. All our safety helmets use the top-quality raw material without any recycling material.
virus mask patterns
We provide exclusive customization of the products logo, using advanced printing technology and technology, not suitable for fading, solid and firm, scratch-proof and anti-smashing, and suitable for various scenes such as construction, mining, warehouse, inspection, etc. Our goal is to satisfy your needs. Demand, do your best.
Professional team work and production line which can make nice quality in short time.
The professional team provides 24 * 7 after-sales service for you, which can help you solve any problems
2/4/2020, · Do Type IIR ,masks, need a ,CE mark, assuming they have passed all tests? EN says the requirements on the packaging are ‚only‘: Both the Medical Device Directive (93/42 / EEC) and the Medical Device Regulation (EU) 2017/745 specify the information that should appear on the packaging in which the medical face ,mask, is supplied.
CE marking, PPE, ,ce mark, PPE, ... If the answer is Yes your product is a medical device or personal protective equipment depending on the intended use; a ,surgical mask, is a medical device; a ,mask, to protect the wearer against microbial and viral infections is personal protective equipment.
Is ,CE marking, a requirement for medical face ,masks,? Yes. According to the Executive Order on Medical Devices, it is required that medical face ,masks, are ,CE, marked when they are advertised and sold within the European market and thus also in Denmark. The ,CE marking, is the manufacturer’s guarantee that the ,mask, complies with current EU legislation.
Surgical masks, are considered first-class medical equipment, and manufacturers must conduct risk analyzes and additional tests in accordance with the European Medical Device Directive 2017/745. After these processes are passed, the manufacturer can put the ,CE mark, on the ,masks,. What is Bacterial Filtration Efficiency Test?
Sterile ,surgical, face ,masks, need to bear a ,CE marking, followed by a 4 -digit code. See also figure below. These 4 digits identify the notified body that assessed the elements for securing and maintaining the sterile conditions. The notified body issues a ,CE, certificate for this purpose.
UPDATE: We have now published our plan and risk assessment for Phase 1 of reopening our office and permanent reopening of our laboratory; please see here for details and here for our Risk Assessment . Subsequent to our previous post regarding the ,CE Marking, of ,surgical masks, used to prevent the spread of the COVID-19 virus, the UK Regulatory Authorities have moved quickly to assist ...
But majority of the manufactures still depend on a third party Certification to get a reputed ,CE, Certificate. [b] Class I Sterile Devices. Class 1 Sterile Device ,CE Marking, process can be completed only by complying with MDD requirements and Harmonized Standards, followed by submitting Technical File to Notified Body and Site Audit.
Non Sterile ,Surgical, Face ,Mask CE Marking, and EU Registration is mandatory for marketing the medical device in the European region. The present European Medical Device Directive (MDD) has to be followed with regard to Class 1 medical devices.. Since it falls under Class 1, Non-Sterile ,Surgical Mask, can be self Certified as per MDD 93/42/EEC.
Single use ,masks, (normally one layer, very thin) are typically only effective at capturing larger dust particles, but can do so fairly well. ,Surgical mask, standards have higher requirements for capturing virus-sized (0.1 micron) particles, however they vary by region. Pollution ,masks, (respirators) typically capture >90% of virus-sized particles.