Safety requirements for secondary cells and batteries

shimonv

Trusted Information Resource
#1
One of the changes introduced with the 3.1 edition is the requirement to test secondary lithium batteries according to IEC 62133.

Do any of you have experience with that? time, cost and if it's feasible to do it in-house instead of external lab.

Thanks,
Shimon
 
Last edited:
Elsmar Forum Sponsor

Mark Meer

Trusted Information Resource
#2
Depends on whether you want to maintain certification or not.

If you DON'T need to maintain certification then, if I recall correctly, we just paid a one-time fee of a few thousand USD, and the battery manufacture had it done through a local accredited test lab, and sent us the test report.

If, however, you want to maintain certification (e.g. maintain an NRTL mark for the 60601), you also - at least according to our NRTL - have to maintain certification of the battery. ...this is a bit more onerous, as it involves semi-annual inspection of the battery manufacturer's facility.

I don't think it's feasible to do in-house (at least without specialized equipment). I believe there are some specific conditioning, charge/discharge, and puncture/short tests that need specific conditions - though it's been awhile since I looked at it, and like I say, we just had a test lab do it...
 
Thread starter Similar threads Forum Replies Date
A Baby food manufacture - food safety requirements Food Safety - ISO 22000, HACCP (21 CFR 120) 0
M Do you need an Applicable general safety and performance requirements Checklist? EU Medical Device Regulations 2
rezayatmand IEC 60601-2-18 Medical electrical equipment - Part 2-18: Particular requirements for the basic safety and essential performance of endoscopic equipmen IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
M Informational EU draft act – Single-use medical devices – safety and performance requirements for reprocessing Medical Device and FDA Regulations and Standards News 0
C CMDR Essential (Safety & Effectiveness) Requirements Checklist? Canada Medical Device Regulations 9
H External power supply - requirements in safety/EMC test? IEC 60601 - Medical Electrical Equipment Safety Standards Series 4
L IATF 16949 requirements for Product Safety Procedures IATF 16949 - Automotive Quality Systems Standard 14
Marc Definition GSPR - General Safety and Performance Requirements Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 0
M Annex I - General Safety and Performance Requirements. Precise identity - how provided EU Medical Device Regulations 6
L IATF 16949 - Requirements for Personnel Safety? IATF 16949 - Automotive Quality Systems Standard 15
T ISO 12100:2010 - Machine Safety Requirements Other ISO and International Standards and European Regulations 8
B China GB4943.1 Safety Requirements - PCB Markings China Medical Device Regulations 0
A VW Supplier Product Safety Representative (PSB) Responsibilities and Requirements VDA Standards - Germany's Automotive Standards 4
Sam Lazzara EU MDR Safety & Performance Requirements vs. MDD ERs (June 2017) EU Medical Device Regulations 3
S FDA Class I Medical Device Safety and Efficacy Data Requirements Other US Medical Device Regulations 5
E Safety Requirements for Bioimpedance Measuring Device Power via USB Cable IEC 60601 - Medical Electrical Equipment Safety Standards Series 3
V VAG Customer Specific Requirements - Product Safety Responsibility Customer and Company Specific Requirements 1
J Electrical Safety Test Requirements for Brazil Other Medical Device Regulations World-Wide 10
S An overview of the automotive safety requirements around the globe; interior products IATF 16949 - Automotive Quality Systems Standard 3
M Incorporating Safety Requirements into Standard Operation Procedure Document Control Systems, Procedures, Forms and Templates 4
M Record Retention requirements for Safety Items Document Control Systems, Procedures, Forms and Templates 7
S Legal Requirements for Test Certificates on Safety Matches for the UK please Supplier Quality Assurance and other Supplier Issues 4
B ISM Code (International Safety Management Code) Requirements and ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
S MDD 93/42/EEC Essential Requirements and Safety definition CE Marking (Conformité Européene) / CB Scheme 2
T Safety & Health Documentation Responsibilities and Requirements (ISO 9001) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Current Products on the Market and IEC 60601 3rd Edition Safety Re-Test Requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 12
S New Draft FDA Guidance on Enforcement of INDs - Safety Reporting Requirements US Food and Drug Administration (FDA) 0
S ISO9001 and "Health and Safety" Procedure Requirements ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
M Basic Legal Requirements for OHS (Occupational Health and Safety) Occupational Health & Safety Management Standards 2
W PHA (Preliminary Hazard Analysis) and Safety Case per UK MOD requirements Occupational Health & Safety Management Standards 2
J Assessing the understanding of occupational health and safety requirements Occupational Health & Safety Management Standards 3
K EN746-2 Industrial thermoprocessing equipment - Safety requirements.... Other ISO and International Standards and European Regulations 1
M 7.2.1.c Product requirements - Determining product, enviroment, health, safety, etc IATF 16949 - Automotive Quality Systems Standard 4
Randy Mexican occupational health and safety requirements Various Other Specifications, Standards, and related Requirements 3
C IEC60601-1 3rd edition +ve vote - Medical Electrical Equipment Safety Requirements IEC 60601 - Medical Electrical Equipment Safety Standards Series 6
R UL Requirements - Received a variation notice - Safety caution text Various Other Specifications, Standards, and related Requirements 3
C VW audit requirements Formel-Q - D/TLD - Safety Part - What is D/TLD? Customer and Company Specific Requirements 8
Gman2 ISO 9001 and Requirements as related to SAFETY - Procedure Control ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 13
dgrainger Informational EU medical device website change from 'Growth' to 'Health and Food Safety' (6/2020) Medical Device and FDA Regulations and Standards News 0
D Safety Assurance Case Report Format ISO 14971 - Medical Device Risk Management 4
B Product Safety Responsibility - Job shop such as a machine shop AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
K Things to learn during lockdown.... Safety-related books/articles/threads Book, Video, Blog and Web Site Reviews and Recommendations 1
JAMESH Job Safety - Lockout/Tagout and Respiratory Protocols Manufacturing and Related Processes 3
J Raw material certificates - CC - Safety products - Sheet metal stamping IATF 16949 - Automotive Quality Systems Standard 1
M Differences in post market safety reporting for Combination Product Applicants Medical Device and FDA Regulations and Standards News 1
S Should safety checks be included in the Control Plan? IATF 16949 - Automotive Quality Systems Standard 5
adir88 Information of safety can reduce risk now? ISO 14971 - Medical Device Risk Management 12
D Is there a specific location for PPE such as safety glass holders and glove dispensers should be mounted Occupational Health & Safety Management Standards 10
S VW Supplier Product Safety Representative (PSB) upgrade to PSCR VDA Standards - Germany's Automotive Standards 4
J FDA wants electrical safety testing on battery powered medical device US Food and Drug Administration (FDA) 11

Similar threads

Top Bottom