I. BIG Changes to Medical Product Certification
The move from the 2nd edition to 3rd edition of 60601 is perhaps the most significant standard update ever within the field of Product Safety. There are three reasons for this:
A) Risk Management Added to Certification:
B) Additional Standards for Compliance:
C) Essential Performance Required:
II. Preparing for the 3rd Edition:
So with the 3rd edition, there are many more standards to comply with, there is a lot more work needed on the Risk Management File, and you must prepare a TRF to the RMF requirements of 60601-1. This is a lot more work. Therefore, expect your Certification costs to double or more, and the completion time to extend considerably longer (actual lab time may not be that much longer but there is a lot more preparation work before you will be ready to send it to the certification lab). The basic steps to preparation are:
A) Product Classifications identified per 60601-1, and -1-11 and -1-12 if applicable
B) Standards Identification: Determine which standards within the 60601 series are applicable including particular standards and, collateral standards such as software, alarms, bio-compatibility, sterilization, PEMS, etc. Several of these standards also reference ISO standards such as ISO62304 and ISO62366.
C) Isolation Diagram created showing method of shock hazard compliance to patient and medical practitioner.
D) Essential Performance for the product identified and defined - medical products are now required to meet "Essential Performance" as a compliance criteria after many of the tests. Special test samples may be necessary to allow for verifying essential performance after each test.
E) Expected Service Life determined including continued use and maintenance. ESL is required input to your Risk Analysis.
F) RMF Review and Preparation: If you do not have an RMF yet, training is recommended to teach you how to develop your RMF so that it is compliant with 60601-1 3rd edition. If you already have an RMF, is it 60601-1 compliant? If not, you will need to review your RMF for compliance with the RMF requirements in 60601-1.
G) Product Pre-Compliance Review: At the very least, have the enclosure and all critical components reviewed for compliance to 60601-1 as well as 60601-1-11 and 60601-1-12 if applicable. Ideally, do a clause by clause preliminary review of these standards.
H) Collateral Standard TRF's: If Usability, Software & Firmware, PEMS, and/or Alarms is applicable, the product must be reviewed to these standards with TRF's prepared during the review process.
I) Test Plan Developed: Summary of all tests, test parameters, and test configurations prepared. Pre- compliance testing should be considered for EMC and any other testing with unpredictable results.
J) Markings, Labeling, & Instructions Review: The 3rd edition has a lot more requirements in this area, this is especially the case with -1-11 and -1-12.
K) US/CAN/CE Certifications: By properly preparing in steps 1-10, you can help avoid compliance failure.
III. Other 3rd Edition Comments:
A) Amendment 1: It is in your best interest to use edition 3.1. However, if you are already compliant with edition 3.0, you are good for awhile.
B) US - UL: The 3rd edition in the USA is not a "UL" standard. The 2nd edition was UL60601-1, but the 3rd edition is managed by AAMI and is known as AAMI ES 60601-1. Consequently, UL Certifications in the US are now done to the AAMI ES 60601-1 standard.
C) US-CAN-CE-INT: This whitepaper is applicable to all versions of the 3rd edition and edition 3.1 of IEC60601-1 including AAMI ES 60601-1, CSA60601-1, and EN60601-1.
Key 3rd Edition Preparation Questions:
CertifiGroup can assist you with all steps in preparing FDA submittals, preparing for compliance to the 3rd edition, and providing US/CAN/CE/International Certification for your products.