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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.

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Solutions to meet different needs

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.

Highly specialized team and products

Professional team work and production line which can make nice quality in short time.

We trade with an open mind

We abide by the privacy policy and human rights, follow the business order, do our utmost to provide you with a fair and secure trading environment, and look forward to your customers coming to cooperate with us, openly mind and trade with customers, promote common development, and work together for a win-win situation.

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The professional team provides 24 * 7 after-sales service for you, which can help you solve any problems

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masks4all map china
In vitro diagnostic (IVD) devices: use safety and ...
In vitro diagnostic (IVD) devices: use safety and ...

Guidance for healthcare professionals covers the use, management and safety ,of in vitro diagnostic, (IVD) devices, including blood glucose meters.

Lists of GHS Precautionary Statement and P Code
Lists of GHS Precautionary Statement and P Code

Updated on 14 April 2015 by Mr Little Pro. [GHS precautionary statement means a standard phrase that describes measures to minimize or prevent adverse effects of a chemical assigned to a hazard class and category.Each precautionary statement is designated a code, starting with the …

In-Vitro Diagnostic (IVD) Test Kits
In-Vitro Diagnostic (IVD) Test Kits

Test ,Kits, for In-,Vitro Diagnosis, (IVD) In-,Vitro Diagnosis, (IVD) refers to a series of assay methods, in which human blood, urine or secretion specimens etc. are tested outside of the human body, so as to find the clinical proof of certain health conditions such as virus infection, diseases, damage to certain organ.

Evaluation of in vitro screening and diagnostic kits for ...
Evaluation of in vitro screening and diagnostic kits for ...

1/8/2018, · In this study, using International ,Standards, for HCV RNA and core antigen (Ag), as well as a recently established RRP, we evaluated in ,vitro diagnostic kits, for HCV infection, including 10 anti-HCV detection ,kits,, two HCV RNA quantification ,kits,, and three HCV core Ag quantification ,kits,, currently available in Japan. 3. Study design 3.1.

GUIDELINES ON THE EVALUATION OF IN VITRO DIAGNOSTIC ...
GUIDELINES ON THE EVALUATION OF IN VITRO DIAGNOSTIC ...

GUIDELINES ON THE EVALUATION ,OF IN VITRO DIAGNOSTIC, MEDICAL DEVICES AND OTHER ,RELATED, LABORATORY ,DIAGNOSTIC, SUPPLIES FOR COVID-19 RATIONALE Pursuant to Republic Act (R.A.) No. 3720 as amended by Republic Act (R.A.) 9711, test ,kits, and in-,vitro diagnostic, reagents must be registered with the Food and Drug Administration

EP25-A: Evaluation of Stability of In Vitro Diagnostic ...
EP25-A: Evaluation of Stability of In Vitro Diagnostic ...

Clinical and Laboratory ,Standards, Institute document EP25-A—Evaluation of Stability ,of In Vitro Diagnostic, Reagents; Approved Guideline provides guidance and regression-based procedures for establishing stability-,related, claims ,of in vitro diagnostic, (IVD) reagents such as reagent ,kits,, calibrators, control products, and sample diluents.

Guidelines on the Evaluation of In Vitro Diagnostic ...
Guidelines on the Evaluation of In Vitro Diagnostic ...

Guidelines on the Evaluation ,of In Vitro Diagnostic, Medical Devices and other ,related, Laboratory ,Diagnostic, supplies for Covid-19 Pursuant to Republic Act (R.A.) No. 3720 as amended by Republic Act (R.A.) 9711, test ,kits, and in-,vitro diagnostic, reagents must be registered with the Food and Drug Administration (FDA) of the Department of Health before release into the Philippine market.

COVID-19 Response - IVD Test Kits | BSI
COVID-19 Response - IVD Test Kits | BSI

3/11/2020, · These ,standards, relate to the manufacture ,of in vitro diagnostic, test ,kits, and IVD medical devices which are undoubtedly in high demand. We will continue to work in collaboration with the Department of Health, MHRA and UK health industry to identify ways we can continue to …

In vitro diagnostic (IVD) devices: use safety and ...
In vitro diagnostic (IVD) devices: use safety and ...

Guidance for healthcare professionals covers the use, management and safety ,of in vitro diagnostic, (IVD) devices, including blood glucose meters.

ISO - ISO 23640:2011 - In vitro diagnostic medical devices ...
ISO - ISO 23640:2011 - In vitro diagnostic medical devices ...

ISO 23640:2011 is applicable to the stability evaluation ,of in vitro diagnostic, medical devices, including reagents, calibrators, control materials, diluents, buffers and reagent ,kits,, hereinafter called IVD reagents.

In vitro diagnostic medical devices | Internal Market ...
In vitro diagnostic medical devices | Internal Market ...

Short name: In ,vitro diagnostic, medical devices. Base: Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in ,vitro diagnostic, medical devices OJ L 331 of 7 December 1998. Modification: [-] Guide for application: Guidance on CE marking for professionals

CDSCO prioritizes Regulatory Approval of In-vitro ...
CDSCO prioritizes Regulatory Approval of In-vitro ...

The Central Drugs Standard Control (CDSCO) released a notification on 19th March, 2020 for paving the way for research and development ,of in-vitro diagnostic kit, for ,diagnosis, of COVID-19. CDSCO is ready to give any form of regulatory guidance ,related, to innovation in development ,of in-vitro diagnostic kit, …

WHO | Laboratory and in vitro diagnostics
WHO | Laboratory and in vitro diagnostics

In ,Vitro Diagnostic, (IVD) tests are a subset of medical devices. In ,vitro diagnostic, tests are used for in ,vitro, examination of specimens derived from the human body to provide information for screening, ,diagnosis,, or treatment monitoring purposes. An IVD test may include reagents provided either in ,kit, format or separately, as well as ...

ISO - ISO 23640:2011 - In vitro diagnostic medical devices ...
ISO - ISO 23640:2011 - In vitro diagnostic medical devices ...

ISO 23640:2011 is applicable to the stability evaluation ,of in vitro diagnostic, medical devices, including reagents, calibrators, control materials, diluents, buffers and reagent ,kits,, hereinafter called IVD reagents.

Overview of IVD Regulation | FDA
Overview of IVD Regulation | FDA

An overview of how the FDA regulates in ,vitro diagnostic, products (IVD). Manufacturers can find detailed information about complying with the Federal, Food, Drug and Cosmetic Act (FD&C Act).

ISO 18113-1:2009(en) In vitro diagnostic medical devices ...
ISO 18113-1:2009(en) In vitro diagnostic medical devices ...

Manufacturers ,of in vitro diagnostic, (IVD) medical devices supply users with information to enable the safe use and expected performance of their devices. Traditionally, this information has been provided in the form of labels, package inserts and user manuals, where the type and level of detail would depend on the intended uses and country-specific regulations.

Infection control - standard and transmission-based ...
Infection control - standard and transmission-based ...

Masks, eye ,protection,, face shields. ,Wear, a mask and eye ,protection,, or a face shield to protect mucous membranes of the eyes, nose and mouth during procedures, patient-care activities and cleaning procedures that are likely to generate splashes or sprays of blood, body fluids, secretions and excretions.

EU Commission Issues New Standards List for In Vitro ...
EU Commission Issues New Standards List for In Vitro ...

The updated list of CEN and Cenelec ,standards, that can be used to support compliance with the Directive was published in January 2015 in the Official Journal of the European Union, and replaces all previously published ,standards, lists for the Directive. View the ,standards, list for the In ,Vitro Diagnostic, Medical Devices Directive. ,Related, Terms:

In Vitro Diagnostics | India - BSI Group
In Vitro Diagnostics | India - BSI Group

As a manufacturer of an in ,vitro diagnostic, (IVD) medical device, you must ensure you meet the relevant requirements outlined in the In ,Vitro Diagnostic, Regulation (IVDR) (EU) 2017/746.. An IVD Medical Device is defined in the IVDR as “any medical device which is a reagent, reagent product, calibrator, control material, ,kit,, instrument, apparatus, piece of equipment, software or system ...