How to elect one product to be representative of a Family of Devices

R

rcjpedro

#1
Hi!

Can anyone please point me in the right direction regarding how to elect one product to be representative of a family of devices? This elected device would then be submitted to a certified laboratory to undergo 60601-1 and 60601-1-2 tests.

Motors creating a vacuum source for anaesthetic gas.

These are very simple devices with no patient contact. They differ only in their capacity. Already certified for industrial use.



Thanks.
 
Elsmar Forum Sponsor

somashekar

Staff member
Super Moderator
#2
Re: Family of Devices

Hi!

Can anyone please point me in the right direction regarding how to elect one product to be representative of a family of devices? This elected device would then be submitted to a certified laboratory to undergo 60601-1 and 60601-1-2 tests.

Motors creating a vacuum source for anaesthetic gas.

These are very simple devices with no patient contact. They differ only in their capacity. Already certified for industrial use.



Thanks.
A good certified lab should be able to assist you in this.
When the motors are of the same construction, but different rating, the highest rating in your family can be considered.
 
Thread starter Similar threads Forum Replies Date
Sidney Vianna Covegratulations to Paul Simpson, Chair-Elect of the ISO TC176 SC2 Covegratulations 8
G Adopting old product - compliance with 62304 IEC 62304 - Medical Device Software Life Cycle Processes 3
S How long does it take to register a product with MHRA? UK Medical Device Regulations 3
D Classification of product for clinical trials EU Medical Device Regulations 9
N Adding unclassified product to the medical device registration US Food and Drug Administration (FDA) 1
B Internal Auditor Competency - Product Auditors Internal Auditing 9
T PFMEA and Control Plans on legacy product FMEA and Control Plans 5
P FDA Approved Product Contact Parts ISO 13485:2016 - Medical Device Quality Management Systems 6
S AS9120B - 8.5.2 Delivering Split Product AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
S Classification of a product according to MDR EU Medical Device Regulations 3
optomist1 Informational Training IMDS - Management of Product Chemical Regulatory Compliance RoHS, REACH, ELV, IMDS and Restricted Substances 2
L AS9100 - Product and Service Provision 8.5.1q AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 6
J 1.11 Preliminary Identification of Special Product and Process Characteristics APQP and PPAP 4
J Possible to get ISO 13485 certified with only OEM Product? ISO 13485:2016 - Medical Device Quality Management Systems 4
Felony Melony New Product Launch - Safe Launch Customer and Company Specific Requirements 1
Marcel DS How do I know if my product is required be RoHS certified? REACH and RoHS Conversations 6
I Control Plan (Product/Process specification/ Tolerance) acceptance FMEA and Control Plans 27
DuncanGibbons Technical Data Package vs Digital Product Definition APQP and PPAP 0
A ISO 11135:2014, B.1.4, BI resistance x product bioburden ISO 13485:2016 - Medical Device Quality Management Systems 6
Sravan Manchikanti How to interpret '8.3 Control of nonconforming product' for SaMD device while implementing ISO 13485 & MDSAP ISO 13485:2016 - Medical Device Quality Management Systems 7
R Product Recall - medical devices in the hospital warehouse Canada Medical Device Regulations 2
A Software bug fixes after shipping a product EU Medical Device Regulations 3
silentmonkey How to measure severity if my product is designed for emergency use and failure would result in death? ISO 14971 - Medical Device Risk Management 9
D IATF16949 7.5.3.2.1 Record Retention - Our Product or Customer Product? Elsmar Cove Forum Suggestions, Complaints, Problems and Bug Reports 1
H Operational planning and product and service provision when things happen so fast ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
T Letter to file for Product Certification CE Marking (Conformité Européene) / CB Scheme 0
J Scope of ISO 9001 clause 10.2 in the product life cycle ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S Can a Contract Manufacturer "release" product on behalf of client to the market? 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
T Formal Q Self Assessment - Problem with assigning Product and Process Customer and Company Specific Requirements 1
S California Cleaning Product Right to Know Act - Product Label advice needed Miscellaneous Environmental Standards and EMS Related Discussions 1
S Definition of "worldwide" in view of IATF 16949 and Product conformity IATF 16949 - Automotive Quality Systems Standard 3
H PCD remains valid for new product ISO 13485:2016 - Medical Device Quality Management Systems 11
M MDR EU Distributor for our CE Mark product in the for Netherlands EU Medical Device Regulations 6
E How do you determine if hipot is necessary for a cable product? Manufacturing and Related Processes 8
D Does Manufacture can submit CE mark application under MDD with NB for his New product after May 2020? EU Medical Device Regulations 3
Ed Panek CE Mark Requirements on Kits (off the shelf product requirements met) CE Marking (Conformité Européene) / CB Scheme 2
N Authorised Representative details on product label? EU Medical Device Regulations 1
D Importing a general wellness low risk product Other US Medical Device Regulations 3
V Process, component or full product re-qualification: leaded to unleaded solder Qualification and Validation (including 21 CFR Part 11) 8
C Brazil - Product Code (and brand) Change Other Medical Device Regulations World-Wide 1
N Audit non-compliance API Q1 - Use of External Documents 4.4.4 in Product Realization Oil and Gas Industry Standards and Regulations 8
S A clinical performance evaluation study with an IVD product as Investagional Use product - Clinical Monitor requirements 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
H Remote product audits in Coivd-19 - IATF 16949 9.2.2.4 IATF 16949 - Automotive Quality Systems Standard 3
B EU MDR Perscription product guidance EU Medical Device Regulations 1
F Product audit sampling plans IATF 16949 - Automotive Quality Systems Standard 3
D Interesting Discussion Requirements for selling a Food product in USA Food Safety - ISO 22000, HACCP (21 CFR 120) 0
D How to list multi-product sample pack in GUDID 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 1
N What is our product classification? (Does Unclassified classification still exists) Other US Medical Device Regulations 14
M Definition of Done - New Product Phase to the sustaining phase Manufacturing and Related Processes 3
B Product Safety Responsibility - Job shop such as a machine shop AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10

Similar threads

Top Bottom