IEC 60601-1 Series
Make a smooth transition with reduced cost and complexity
With the publication of IEC 60601-1:2005 (3rd Edition), medical device manufacturers must be aware of the varying regulatory transition periods worldwide. Some countries and regions are changing over to accept medical electrical equipment that complies with the third edition or even require to include the latest amendment IEC 60601-1:2005+A1:2012, while other markets will continue to recognise the 2nd previous edition for a limited time.
IEC 60601-1:2005 contains nearly 700 entirely new or more stringent requirements compared to the prior edition, and risk management has become a crucial requirement. Manufacturers must now estimate the probability of risks occurring with their products in conformance to ISO 14971 - Application of Risk Management to Medical Devices, and these estimates may be challenged at each approval level or destination market. Taken together, all these requirements increase the complexity and associated costs of transition to the new edition.
IEC 60601 is a series of technical standards that ensure the safety and essential performance of medical electrical equipment. IEC 60601-1:2005 deals with the basic safety and essential performance requirements of medical electrical equipment, and serves to ensure that no single electrical, mechanical or functional failure shall pose an unacceptable risk to patients and operators. Public health authorities in many countries recognise IEC 60601-1:2005 as a pre-requisite for the commercialisation of electrical medical equipment.
IEC 60601-1:2005 and its A1 version IEC 60601-1:2005+A1:2012 become more and more widely accepted in the U.S., Canada, the EU, Japan, Brazil and Russia. Some major import countries for medical equipment, enforces the implementation of the third edition, because they recognise this standard as state of the art. To avoid being denied entry into these and other markets, manufacturers should ensure that their products comply with both the second and third editions of the standard.
Our experts actively participate in international advisory bodies and standardisation committees. This industry leading expertise underpins the wide public awareness and first-class international reputation of the TÜV SÜD brand.
TÜV SÜD Product Service offers a full suite of testing and certification services for this standard that can be provided at our state-of-the-art facilities or on-site at your premises.
- Product testing - We operate some of the world’s most sophisticated test laboratories, which are capable of testing products to various electromagnetic compatibility, environmental and electrical safety and performance standards.
- Certification - TÜV SÜD Product Service provides certification to safety standards and international standards (e.g. CB scheme and NRTL certification) to assist you in gaining market access for your products.
With over 400 dedicated medical health and services experts situated in major markets worldwide, TÜV SÜD Product Service is the largest Notified Body in the world. We also have a dedicated Regulatory Foreign Affairs & Clinical Affairs Department to monitor developments in regulations for medical health services and devices globally.
With the widest range of accreditations, we possess an in-depth understanding of international standards and the medical health services sector. This enables us to save our clients time and money by conducting multiple certification processes simultaneously. In addition to regulatory and quality assurance expertise, TÜV SÜD Product Service’s experts are also skilled in advanced medical device assessments for functional and software safety, especially related to essential performance.
IEC 60601 is a series of technical standards that ensure the safety and essential performance of medical electrical equipment. IEC 60601-1:2005 deals with the basic safety and essential performance requirements of medical electrical equipment, and serves to ensure that no single electrical, mechanical or functional failure shall pose an unacceptable risk to patients and operators. Public health authorities in many countries recognise IEC 60601-1:2005 as a pre-requisite for the commercialisation of electrical medical equipment.
IEC 60601-1:2005 and its A1 version IEC 60601-1:2005+A1:2012 become more and more widely accepted in the U.S., Canada, the EU, Japan, Brazil and Russia. Some major import countries for medical equipment, enforces the implementation of the third edition, because they recognise this standard as state of the art. To avoid being denied entry into these and other markets, manufacturers should ensure that their products comply with both the second and third editions of the standard.
Our experts actively participate in international advisory bodies and standardisation committees. This industry leading expertise underpins the wide public awareness and first-class international reputation of the TÜV SÜD brand.
TÜV SÜD Product Service offers a full suite of testing and certification services for this standard that can be provided at our state-of-the-art facilities or on-site at your premises.
- Product testing - We operate some of the world’s most sophisticated test laboratories, which are capable of testing products to various electromagnetic compatibility, environmental and electrical safety and performance standards.
- Certification - TÜV SÜD Product Service provides certification to safety standards and international standards (e.g. CB scheme and NRTL certification) to assist you in gaining market access for your products.
With over 400 dedicated medical health and services experts situated in major markets worldwide, TÜV SÜD Product Service is the largest Notified Body in the world. We also have a dedicated Regulatory Foreign Affairs & Clinical Affairs Department to monitor developments in regulations for medical health services and devices globally.
With the widest range of accreditations, we possess an in-depth understanding of international standards and the medical health services sector. This enables us to save our clients time and money by conducting multiple certification processes simultaneously. In addition to regulatory and quality assurance expertise, TÜV SÜD Product Service’s experts are also skilled in advanced medical device assessments for functional and software safety, especially related to essential performance.
Your benefits at a glance
- Save time and money - by ensuring your product is compliant to both editions in your first prototype, thereby avoiding costly delays in redesign.
- Minimise risk - with redesign development right from the beginning.
- Benefit from global support - with engineers in your local markets that speak your language and are capable of conducting tests and audits one after the other.
- Work with a single-source partner - that is an internationally recognised testing body with a strong presence in major markets worldwide.