imgalt

GOST R 57502-2017

ГОСТ Р 57502-2017

Medical equipment. Industrial production regulation

Изделия медицинские. Промышленный регламент производства

Status: Effective - Introduced for the first time. IUS 10-2017

This standard establishes the general requirements for the content of industrial regulations on the production of medical devices (MIs) and their components.

Настоящий стандарт устанавливает общие требования к содержанию промышленных регламентов производства (ПРП) медицинских изделий (МИ) и их составных частей

Choose Language: 
Format: Electronic (pdf/doc)

Approved: Federal Agency for Technical Regulation and Metrology, 6/8/2017

SKU: RUSS288459

Price: $349.00



imgalt

The Product is Contained in the Following Classifiers:

PromExpert » SECTION I. TECHNICAL REGULATION » I Basics of technical regulation » 1 The main provisions of technical regulation »

ISO classifier » 11 HEALTH » 11.040 Medical equipment » 11.040.01 Medical equipment in general »

National standards » 11 HEALTH » 11.040 Medical equipment » 11.040.01 Medical equipment in general »


The Document References:

GOST 12.0.002-2014: System of labor safety standards Terms and definitions

GOST 12.1.004-91: Fire safety. General requirements

GOST 12.1.005-88: General sanitary requirements for working zone air

GOST 12.1.007-76: Noxious substances. Classification and general safety requirements

GOST 12.1.044-89: Fire and explosion hazard of substances and materials. Nomenclature of indices and methods of their determination

GOST 12.3.002-2014: System of labor safety standards Production processes. General safety requirements.

GOST 12.4.011-89: Occupational safety standards system. Means of protection. General requirements and classification

GOST 12.4.021-75: Ventilation systems. General requirements

GOST 17.2.3.02-2014: Regulations for establishing permissible limits of harmful pollutants emissions from industrial enterprises

GOST 18322-2016: Maintenance and repair system of engineering. Terms and definitions

GOST 2.101-2016: Unified system for design documentation. Unified system for design documentation

GOST 2.102-2013: Unified system for design documentation. Types and sets of design documentation

GOST 2.105-95: General requirements for writing documents

GOST 2.106-96: Unified system for design documentation. Text documents

GOST 26140-84: Medical x-ray units

GOST 3.1105-2011: Unified system of technological documentation. Form and rules of making general-purpose documents

GOST 3.1109-82: Unified system for technological documentation. Terms and definitions of main concepts

GOST 3.1120-83: Unified system of technological documentation. General rules for presentation of labour safety requirements in technological documentation

GOST 3.1122-84: Unified system of technological documentation. Forms and rules for filling in documents for special use. Technological registers

GOST 3.1123-84: Unified system for technological documentation. Forms and rules for drawing up documents used in setting of proper rates of material consumption

GOST 30772-2001: Resources saving. Waste treatment. Terms and definitions

GOST ISO 13485-2011: Medical devices. Quality management systems. System requirements for regulatory purposes

GOST ISO 14971-2011: Medical devices. Application of risk management to medical devices

GOST R 12.1.019-2009: Occupational safety standards system. Electrical safety. General requirements and nomenclature of kinds of protection

GOST R 12.3.047-2012: Occupational safety standards system. Fire safety of technological processes. General requirements. Methods of control

GOST R 50444-92: Medical instruments, apparatus and equipment. General specifications

GOST R 51897-2011: Risk management. Terms and definition

GOST R 51898-2002: Safety aspects. Guidelines for their inclusion in standards

GOST R 7.0.8-2013: System of standards on information, librarianship and publishing. Records management and organization of archives. Terms and definitions

GOST R IEC 60601-1-2010: Medical electrical equipment. Part 1. General requirements for basic safety and essential performance (IEC 60601-1:1988, IEC 60601-2-17(2004))

GOST R ISO 14041-2000: Environmental management. Life cycle assessment. Goal and scope definition and inventory analysis

RD 09-251-98: Provision on procedure of formulation and content of section “safety operation of production plant” of process regulations

Resolution 469: On Approval of the Regulation on licensing activities for the production and maintenance (except for the case when maintenance is performed to meet the own needs of a legal entity or individual entrepreneur) of medical equipment

SanPiN 2.1.7.1322-03: Hygienic requirements regarding dumping and decontamination of industrial and consumable waste

SP 30.13330.2012: Domestic water supply and sewerage of buildings.

SP 60.13330.2012: Heating, Ventilation and Air Conditioning (HVAC). Updated living edition of SNiP 41-01-2003

Customers Who Viewed This Item Also Viewed:

imgalt imgalt
Building materials. Methods for combustibility test
Language: English
Price: $162.00
imgalt
Cylindrical evolvent gears of external engagment. Strength calculation
Language: English
Price: $745.00
imgalt
Building materials spread flame test method
Language: English
Price: $147.00
imgalt
Food products, food raw materials. Method for determination of the non-steroidal anti-inflammatory drug residue content by high performance liquid chromatography – mass spectrometry
Language: English
Price: $349.00
imgalt
Steel welded vessels and apparatus. General technical conditions
Language: English
Price: $549.00
imgalt
Plywood for general use with outer layers of deciduous veneer. Specifications
Language: English
Price: $414.00
imgalt
System of Standards for Occupational Safety and Health (SSBT). Personal protective equipment for respiratory organs. Self-rescuers insulating on chemically bound or with compressed oxygen. Technical requirements. Test methods. Marking. Sampling rules
Language: English
Price: $700.00
imgalt

YOUR ORDERING MADE EASY!

RussianGost.com is an industry-leading company with stringent quality control standards and our dedication to precision, reliability and accuracy are some of the reasons why some of the world’s largest companies trust us to provide their national regulatory framework and for translations of critical, challenging, and sensitive information.

Our niche specialty is the localization of national regulatory databases involving: technical norms, standards, and regulations; government laws, codes, and resolutions; as well as RF agency codes, requirements, and Instructions.

We maintain a database of over 220,000 normative documents in English and other languages for the following 12 countries: Armenia, Azerbaijan, Belarus, Kazakhstan, Kyrgyzstan, Moldova, Mongolia, Russia, Tajikistan, Turkmenistan, Ukraine, and Uzbekistan.

Placing Your Order

Please select your chosen document, proceed to the ‘checkout page’ and select the form of payment of your choice. We accept all major credit cards and bank wire transfers. We also accept PayPal and Google Checkout for your convenience. Please contact us for any additional arrangements (Contract agreements, PO, etc.).

Once an order is placed it will be verified and processed within a few hours up to a rare maximum of 24 hours.

For items in stock, the document/web link is e-mailed to you so that you can download and save it for your records.

For items out of stock (third party supply) you will be notified as to which items will require additional time to fulfil. We normally supply such items in less than three days.

Once an order is placed you will receive a receipt/invoice that can be filed for reporting and accounting purposes. This receipt can be easily saved and printed for your records.

Your Order Best Quality and Authenticity Guarantee

Your order is provided in electronic format (usually an Adobe Acrobat or MS Word).

We always guarantee the best quality for all of our products. If for any reason whatsoever you are not satisfied, we can conduct a completely FREE revision and edit of products you have purchased. Additionally we provide FREE regulatory updates if, for instance, the document has a newer version at the date of purchase.

We guarantee authenticity. Each document in English is verified against the original and official version. We only use official regulatory sources to make sure you have the most recent version of the document, all from reliable official sources.

All Codes and Regulations

All Categories

Send us a message Expand Collapse

Leave your message in the form below, and we will write back by e-mail!