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.
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