Is EN ISO 10079-1 same as YY 0636.1? (Medical Suction Equipment)

M

michaelpui

#1
we are looking for a product import to EU, but the manufacturer applied YY 0636.1 and they claimed that TUV accepted both standards are same and issued CE to them.

however, this is funny because they come from different countries.

what do you think?
Thanks for the help!
 
Elsmar Forum Sponsor

SteveK

Trusted Information Resource
#2
Without getting a copy of YY 0636.1 (there appears to be an English version), references to the Chinese Standard indicates that ISO10079-1 is the ?Adopted Standard?. So it is likely that it is basically a facsimile of ISO 10079-1 to fit into a Chinese format and therefore both Standards are probably equivalent (from a NB perspective).

Look at the Information Documents in:

http://www.imdrf.org/documents/documents.asp

That's my best shot!

Steve
 
Thread starter Similar threads Forum Replies Date
R ISO 10079-1:2014 on electric powered nasal aspirator Other US Medical Device Regulations 0
K Searching for any information regarding ISO 10079-1 - Vacuum Collection Canisters Other Medical Device Related Standards 6
J How much to charge for helping a startup company with initial ISO 13485 certification? Consultants and Consulting 3
J ISO 13485 System 'soft start' - How to best reflect this in initial audits, management review minutes and other records? ISO 13485:2016 - Medical Device Quality Management Systems 3
L How to understand the clause 6 Planning of ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
D ISO 13485 - 7.3.6 Design and development verification - Do most folks create a separate SOP? ISO 13485:2016 - Medical Device Quality Management Systems 4
B ISO 8536-4 Contamination Index ISO 13485:2016 - Medical Device Quality Management Systems 0
S Practical Implementation of ISO 14971 ISO 14971 - Medical Device Risk Management 6
C ISO 13485 :2016 - CAPA - Does every CAPA need to be checked by regulations? ISO 13485:2016 - Medical Device Quality Management Systems 9
L Process changes and biocompatibility (ISO 10993-1) Other Medical Device Related Standards 1
J Recommendations for online ISO 19011 training? Training - Internal, External, Online and Distance Learning 6
D ISO 13485 8.2.1 and 8.2.2 - Customer Feedback and Customer Complaints ISO 13485:2016 - Medical Device Quality Management Systems 5
S Requirements to obtain ISO 50001 Certification ISO 14001:2015 Specific Discussions 2
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 4
J Sister-company providing parts is only ISO 9001 registered IATF 16949 - Automotive Quality Systems Standard 7
M Getting started in ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 21
G Copy of withdrawn ISO 9001:1994 Quality Management Standard ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
P ISO 80369 and endoscope port/lumen Other ISO and International Standards and European Regulations 4
C ISO 639-1 Languages Other Medical Device Related Standards 0
B ISO 11607-2 "Critical Parameter" vs. "Process Parameter" Other Medical Device Related Standards 3
S ECG Cable Banana to Snap or Tab electrode Adapters -- ISO 10993 Requirement Other Medical Device Related Standards 0
I ISO 2233:2000 Question - Medical Device Shipping/Transportation Validation Other ISO and International Standards and European Regulations 1
P ISO Class 8 particle count (annual certification vs monitoring) ISO 13485:2016 - Medical Device Quality Management Systems 4
T ISO/IEC 17065 certification scheme Help Other ISO and International Standards and European Regulations 7
A Does ISO 9001:2015 cover all the requirements of ISO 10012:2003? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
G Logistic organization and controls - IATF/ISO 9001 audit Nonconformance and Corrective Action 2
R Identify Medical Device characterstics as Annex C of ISO 14971 Risk Management ISO 14971 - Medical Device Risk Management 5
A ISO 17021-1:2015 toolkit General Auditing Discussions 2
N ISO 19011:2018 - 5.4.2 "...audit program should engage in appropriate continual development..." Training - Internal, External, Online and Distance Learning 4
P ISO 13485:2016 MDSAP Certification Fee Survey ISO 13485:2016 - Medical Device Quality Management Systems 6
A ISO 14971 PFMEA Manufacturing Risk ISO 14971 - Medical Device Risk Management 2
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
C SOP Template needed for ISO 13485 6.3 Infrastructure ISO 13485:2016 - Medical Device Quality Management Systems 9
T ISO 13485 8.3 - Non-Conforming Materials - on-line rework or part of process? ISO 13485:2016 - Medical Device Quality Management Systems 11
T ISO 9001 8.5.2. - Identification and traceability to Identify Outputs - Services ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
T Outsourced process in ISO 45001 Occupational Health & Safety Management Standards 2
K Overall residual risk according to ISO 14971:2019 ISO 14971 - Medical Device Risk Management 5
M Gap analysis on ISO 14971:2019 with previous revision ISO 14971 - Medical Device Risk Management 3
T ISO 9001:2015 - Small Shop ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 7
T ISO 17025:2017 requirement 5.7.b. about maintenance the integrity of the management system ISO 17025 related Discussions 1
M ISO 9001:2015 case study sample ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Sample of Nonconformity report for ISO 9001:2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Q ISO 9001 8.5.1 - Control of production and service performance ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
B Do IFU designs have to be document controlled under ISO 13485? Document Control Systems, Procedures, Forms and Templates 2
H ISO 13485 - Separate Microbiology Audits ISO 13485:2016 - Medical Device Quality Management Systems 3
M Case study help as per ISO 9001: 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 17
M Case study solution help required as per ISO 9001 : 2015 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
C Production and Post Production feedback - ISO 13485 ISO 13485:2016 - Medical Device Quality Management Systems 4
B New ISO 14971:2019 Harm: unreasonable psychological stress, and cybersecurity ISO 14971 - Medical Device Risk Management 13

Similar threads

Top Bottom