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BS EN ISO 11197:2019

Medical supply units

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Standard number:	BS EN ISO 11197:2019
Pages:	46
Released:	2019-12-10
ISBN:	978 0 580 51313 8
Status:	Standard

BS EN ISO 11197:2019 Medical Supply Units

In the ever-evolving world of healthcare, ensuring the highest standards of safety, efficiency, and reliability is paramount. The BS EN ISO 11197:2019 Medical Supply Units standard is a comprehensive guide that sets the benchmark for medical supply units, ensuring they meet the rigorous demands of modern medical environments.

Overview

Released on December 10, 2019, this standard is a crucial document for manufacturers, healthcare providers, and regulatory bodies involved in the design, production, and implementation of medical supply units. With a total of 46 pages, it provides detailed guidelines and specifications to ensure that medical supply units are safe, effective, and compliant with international standards.

Key Features

Standard Number: BS EN ISO 11197:2019
Pages: 46
Release Date: December 10, 2019
ISBN: 978 0 580 51313 8
Status: Standard

Why Choose BS EN ISO 11197:2019?

The BS EN ISO 11197:2019 standard is essential for ensuring that medical supply units are designed and manufactured to the highest quality. Here are some reasons why this standard is indispensable:

Comprehensive Guidelines: The standard provides a thorough set of guidelines that cover all aspects of medical supply units, from design and materials to installation and maintenance.
International Compliance: As an ISO standard, it ensures that medical supply units meet international requirements, facilitating global trade and cooperation.
Enhanced Safety: By adhering to this standard, manufacturers can ensure that their products are safe for use in medical environments, reducing the risk of accidents and malfunctions.
Quality Assurance: The standard helps maintain a high level of quality in medical supply units, ensuring they perform reliably and effectively.

Applications

Medical supply units are critical components in healthcare facilities, providing essential services such as electrical power, medical gases, and data communication. The BS EN ISO 11197:2019 standard is applicable to a wide range of medical environments, including:

Hospitals
Clinics
Emergency Rooms
Intensive Care Units
Operating Theatres

Who Should Use This Standard?

This standard is designed for a variety of stakeholders in the healthcare industry, including:

Manufacturers: To ensure their products meet international standards and are safe for use in medical environments.
Healthcare Providers: To ensure the medical supply units they use are reliable and compliant with the latest standards.
Regulatory Bodies: To enforce compliance and ensure the safety and effectiveness of medical supply units.

Conclusion

The BS EN ISO 11197:2019 Medical Supply Units standard is an essential resource for anyone involved in the design, manufacture, or use of medical supply units. By adhering to this standard, stakeholders can ensure that their products and services meet the highest levels of safety, quality, and international compliance. Whether you are a manufacturer looking to enhance your product offerings or a healthcare provider seeking to ensure the safety and reliability of your equipment, this standard is an invaluable tool in achieving your goals.

DESCRIPTION

BS EN ISO 11197:2019

This standard BS EN ISO 11197:2019 Medical supply units is classified in these ICS categories:

11.040.10 Anaesthetic, respiratory and reanimation equipment

IEC 60601‑1:2005+A1:2012, Clause 1 applies except as follows:

201.1.1 Scope

IEC 60601‑1:2005+A1:2012, 1.1 is replaced by:

This document applies to the basic safety and essential performance of medical supply units, hereafter also referred to as ME equipment.

This document applies to medical supply units manufactured within a factory or assembled on site, including cabinetry and other enclosures, which incorporate patientcare services.

NOTE 1 A party that assembles on site various components intended for patient care services into an enclosure is considered the manufacturer of the medical supply unit.

Hazards inherent in the intended function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this standard, except in of IEC 60601‑1:2005+A1:2012, 7.2.13 and 8.4.1 (see 201.1.4).

NOTE 2 Refer to IEC 60601‑1:2005+A1:2012, 4.2.

201.1.2 Object

IEC 60601‑1:2005+A1:2012, 1.2 is replaced by:

The object of this document is to establish particular basic safety and essential performance requirements for medical supply units as defined in 201.3.201.

201.1.3 Related standards

201.1.3.1 General and Collateral standards

IEC 60601‑1:2005+A1:2012, 1.3 applies as the General Standard with the following addition:

This particular standard refers to those applicable collateral standards that are listed in IEC 60601‑1:2005+A1:2012, Clause 2 as well as 201.2 of this particular standard.

IEC 60601‑1‑3:2008+A1:2013, IEC 60601‑1‑8:2006+A1:2012, IEC 60601‑1‑9:2007, IEC 60601‑1‑10:2007+A1:2013 and IEC 60601‑1‑11 and IEC 60601‑1‑12 do not apply.

NOTE Collateral standards are referred to by their document numbers.

201.1.3.2 Particular standards

IEC 60601‑1:2005+A1:2012, 1.4 applies with the following additions:

The numbering of sections, clauses and subclauses of this particular standard corresponds to that of IEC 60601‑1:2005+A1:2012 with the prefix “201” (e.g. 201.1 in this standard addresses the content of IEC 60601‑1:2005+A1:2012 Clause 1) or applicable collateral standard with the prefix “20x” where x is the final digit(s) of the collateral standard document number (e.g. 202.4 in this particular standard addresses the content of Clause 4 of the IEC 60601‑1‑2 collateral standard, 203.4 in this particular standard addresses the content of Clause 4 of the IEC 60601‑1‑3 collateral standard, etc.). The changes to the text of IEC 60601‑1:2005+A1:2012 are specified by the use of the following words:

“Replacement” means that the clause or subclause of IEC 60601‑1:2005+A1:2012 or applicable collateral standard is replaced completely by the text of this particular standard.
“Addition” means that the text of this particular standard is additional to the requirements of IEC 60601‑1:2005+A1:2012 or applicable collateral standard.
“Amendment” means that the clause or subclause of IEC 60601‑1:2005+A1:2012 or applicable collateral standard is amended as indicated by the text of this particular standard.

Subclauses or figures which are additional to those of IEC 60601‑1:2005+A1:2012 are numbered starting from 201.101. Additional Annexes are lettered AA, BB, etc., and additional items aa), bb), etc.

Subclauses or figures which are additional to those of a collateral standard are numbered starting from 20x, where “x” is the number of the collateral standard, e.g. 202 for IEC 60601‑1‑2, 203 for IEC 60601‑1‑3, etc.

The term “this standard” is used to make reference to IEC 60601‑1:2005+A1:2012, any applicable collateral standards and this particular standard taken together.

Where there is no corresponding section, clause or subclause in this particular standard, the section, clause or subclause of IEC 60601‑1:2005+A1:2012 or applicable collateral standard, although possibly not relevant, applies without modification; where it is intended that any part of IEC 60601‑1:2005+A1:2012 or applicable collateral standard, although possibly relevant, is not to be applied, a statement to that effect is given in this particular standard.