It is always a good idea to review basic safety requirements applicable to products under development. This helps reduce the chance of overlooking minor technical details that may lead to costly mistakes if the design team needs to make physical changes to the product during the safety approval process.
This recorded webinar provides a technical overview of areas of concern in regards to non-conformities that could delay a product from getting to market on time during product design prototyping stages, and prior to testing and final certification to IEC 61010-1, the Standard for Safety Requirements for Electrical Equipment for Measurement, Control, and Laboratory Use. Examples of these types of equipment include PCR thermal cyclers, laboratory freezers, ovens, sterilizers, mixers, spectrometers, centrifuges, multimeters and insulation testers. In addition, In-Vitro Diagnostic (IVD) products fall under the scope of IEC 61010-1 with IEC 61010-2-101 being the specific standard.
Key points:
- Introduction of IEC 61010-1 Edition 3.1
- Overview of IEC 61010 series and requirements
- Challenges IVD manufacturers face in meeting these safety requirements
Speakers:
Ms. Lee Chen Chen
Chenchen is a project reviewer and program manager with UL in Taiwan with 15 years of experience in the certification field for IEC 61010-1 and IEC 60601-1. She has conducted various trainings on IEC 61010-1 and IEC 60601-1 in the region and is a subject matter expert in the two standards. In addition, Chenchen is a ISO/IEC 17025 lead auditor and technical auditor for IECEE CB Scheme for MEAS and MED categories.
Mr. Zhuo Guoping
Guoping is a project handler with UL in Singapore with 6 years of experience in evaluation of laboratory and medical products, with compliance to IEC 61010-1 and IEC 60601-1 series. He is the signatory for local SAC and IECEE CB Scheme for the two product categories. Prior to UL, Guoping was in a medical manufacturing industry for three years in R&D as a product development engineer.
Webinar date:
July 15, 2021