Types of Standards and Harmonized Standards

E

Ethan Loh

#1
Hi everybody,

Can anyone tell me what is the differences between the following standards?

1. Harmonized standard such as EN 980:2008
2. BS EN, DIN EN, etc....
3. ISO standards


My company had a few Technical Files for CE mark and it is a must to comply to the harmonized standards?

What happened if we do not comply to the harmonized standard but only to the ISO standards?

Please advise :D
 
Elsmar Forum Sponsor

Marcelo

Inactive Registered Visitor
#2
Re: Types of standards

Hello Ethan

Can anyone tell me what is the differences between the following standards?

1. Harmonized standard such as EN 980:2008
2. BS EN, DIN EN, etc....
3. ISO standards
An ISO or IEC standard is a INTERNATIONAL standard, published by an international SDO - standard development organization, meaning it´s generally recognized by the members bodies of ISO and IEC as the standard on the subject.

Standards are by default voluntary. Countries or regions (case of the EU), when they want to use standards in their regulations, have to call them in the regulation to make it an option or mandatory or whatever.

Due to a lot of reasons, countries or regions usually cannot directly use an international standard...they have to use a country or region specific version of the standard. These are developed by SDOs from countries or regions.

In the case of the EU, the SDOs are CEN or CENELEC (the EU ISO and IEC) which publishes EN standards (European Norms).

Harmonized standards are related to the directives in place on the EU. Basically, directives gives essential, general requirements, and harmonized standards provide more detailed requirements. Please note that, although harmonized standards are considered the "gold standard" on the subject (state of the art) they are are still voluntary - the manufacturer of the device can use any technical solution thet they see fit. The problem here is that compliance with harmonized standards gives what the directives call "presumption of conformity" with the related essential requirements. Oher standards or other solutions do not give this. So if not using an harmonized standard, you will need to justiry (in your risk management file) that the level of safety your product has is the nsame as if using a harmonized standard.

Finally, due to a lot of other reasons (mainly new approach directives and the global approach framework), countries in the EU have to have their own version of harmonized standards, or have to accept the general EU standard as a national standard. That´s why we have BS EN (british implementation of the EU standard), DIN EN (german implementation of the EU standard) and etc.
 
Last edited:
Z

zolakeene

#3
Hi

Happy Nerw Year

Can anyone help me?

I am trying to find a standard that relates to corrugated tubing for the medical industry?

many thanksa
Zola
 
S

SteveK

#4
Hi Zola,

The only standard I am aware of is BS EN 13544-2:2002 "Respiratory therapy equipment - Part 2: Tubing and connectors".

It is not specific to corrugated tubing, but it indicates a test for resistance to kinking, security of connectors, the fact that it is oxygen compatible etc. Not very detailed, but often some of the medical device standards are basic.

It is possible there are some references in other (harmonised) standards e.g. Lung Ventilator series - EN ISO 10651 - but I do not have copies of these so cannot comment.

I hope this is of some help.

Steve
 
Z

zolakeene

#5
Hi Guys

Can any give me a shove in the right direction need to prepare a presentation "Implementation of production operator led inspection, requirements and strategy£
 
D

DynaPur

#6
Re: Types of standards

Marcelo, I just registered with ELSMAR yesterday and was searching for answers on this same topic for a non-medical field but I'm sure your info still applies.

Just to clarify, an IEC standard would NOT be a Harmonised Standard on an EU DoC, correct? We have a DoC from very large global manufacturer that is listing just IEC standards. Our client (who requested the DoC) said this is not acceptable. The supplier sent back the CENELEC listing of the 61326-2-1:2006 standard. The EN version is listed at the top of the listing paragraph and the paragraph concludes with the IEC version of the same. As a newcomer to the whole CE marking process, basic logic would dictate that the EN standard is what one would list so the manufacturer's "justification" for using IEC vs. EN coupled with your info means to me that the supplier's justification doesn't really hold water.

Do you have any suggestions (the Europa website aside) where I could find concise information as to what is required on EU DoC's?
 

renenatasha

Involved In Discussions
#7
Re: Types of standards

Hello Ethan



An ISO or IEC standard is a INTERNATIONAL standard, published by an international SDO - standard development organization, meaning it?s generally recognized by the members bodies of ISO and IEC as the standard on the subject.

Standards are by default voluntary. Countries or regions (case of the EU), when they want to use standards in their regulations, have to call them in the regulation to make it an option or mandatory or whatever.

Due to a lot of reasons, countries or regions usually cannot directly use an international standard...they have to use a country or region specific version of the standard. These are developed by SDOs from countries or regions.

In the case of the EU, the SDOs are CEN or CENELEC (the EU ISO and IEC) which publishes EN standards (European Norms).

Harmonized standards are related to the directives in place on the EU. Basically, directives gives essential, general requirements, and harmonized standards provide more detailed requirements. Please note that, although harmonized standards are considered the "gold standard" on the subject (state of the art) they are are still voluntary - the manufacturer of the device can use any technical solution thet they see fit. The problem here is that compliance with harmonized standards gives what the directives call "presumption of conformity" with the related essential requirements. Oher standards or other solutions do not give this. So if not using an harmonized standard, you will need to justiry (in your risk management file) that the level of safety your product has is the nsame as if using a harmonized standard.

Finally, due to a lot of other reasons (mainly new approach directives and the global approach framework), countries in the EU have to have their own version of harmonized standards, or have to accept the general EU standard as a national standard. That?s why we have BS EN (british implementation of the EU standard), DIN EN (german implementation of the EU standard) and etc.
Hi Marcelo,

I'm quite new to this so-called "Harmonized Standard" too. As far as I can recall, I thought we only have to note down those we use (or comply)? Hmm... is my understanding correct? Or we have to note whatever that relates? Oh BTW, the harmonized standards are only mentioned in the Essential Requirement and not in the Risk Management. Is this alright?

Sorry for the endless questions :D
Anyway, thanks for your advice. It's been of great help. - Rene
 
Thread starter Similar threads Forum Replies Date
J BS EN131-1:2007 Standards (Ladders, Specification for terms, types, functional sizes) Other ISO and International Standards and European Regulations 1
H CAPA effectiveness verification methods for different types of CA Nonconformance and Corrective Action 3
B Where do the definitions of the types of processes come from? IATF 16949 - Automotive Quality Systems Standard 9
T Types of confidential information ISO 17025 related Discussions 8
L Allowable AC mains fuse types for latest IEC60601 IEC 60601 - Medical Electrical Equipment Safety Standards Series 2
A Torque Value for Different types of Fasteners (Socket Head, Button Head, CSK) Manufacturing and Related Processes 2
C PCBA Hardware Component different failure types - How to rate detection? FMEA and Control Plans 8
E Different types of Actions? CARs, OFIs or N/A ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
S The key differences in 510k types - Traditional vs. Abbreviated vs. Special US Food and Drug Administration (FDA) 0
R ISO9001 & ISO13485 QMS for 2 types of products ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Rameshwar25 Other types of Control Charts described in Chapter II of SPC Manual Statistical Analysis Tools, Techniques and SPC 6
P Any official doc/spec on different types of Yield calculation? Manufacturing and Related Processes 0
B IATF 16949 Cl. 9.2.2.1 - Internal audit program - Types of evidence Internal Auditing 1
S ITAR Document Types and Training Other ISO and International Standards and European Regulations 6
Q Where to include other types of Nonconformities ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
R 21 CFR Part 820.186 - Types of Quality System Records Document Control Systems, Procedures, Forms and Templates 1
C What types of Calibration Metrics are Collected General Measurement Device and Calibration Topics 2
S Double Thermocouple - Two types, same sheath (AMS2750/Nadcap) Manufacturing and Related Processes 9
S Clarification regarding types of processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
E Types of nonactive Medical Device implants - What is the origin of this codification? EU Medical Device Regulations 6
M Types of Controlled Documentation - Call Lists of Emergency Contacts Quality Manager and Management Related Issues 5
M Process Approach: Types & number of processes required? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 19
G Comparison Study of CMMs and software along with Probe Types Inspection, Prints (Drawings), Testing, Sampling and Related Topics 12
V CMM plane construction method types and accuracy differences for measuring Pos Tol Inspection, Prints (Drawings), Testing, Sampling and Related Topics 4
S Latest types of Fire Extinguishers in India Misc. Quality Assurance and Business Systems Related Topics 1
L Capability studies on machine types - Supplier has over 1000 machines Quality Manager and Management Related Issues 7
I Types of Internal Audit findings based on ISO 9001 Clause 8.2.2 Quality Manager and Management Related Issues 10
C Chrysler Quality Definitions? Chrysler has identified six types of quality Quality Manager and Management Related Issues 1
C AUDITS! Different types of audits and what they mean? General Auditing Discussions 9
U Dial Gages of all types in company flood - How to recover them General Measurement Device and Calibration Topics 6
Z KFDA (Korea) Device Change Regulations - What are 32 Types of Changes Exempted? Other Medical Device Regulations World-Wide 2
E Implementing Risk Management - Required Document Types ISO 14971 - Medical Device Risk Management 8
P NQA-1 Requirement 17 Quality Records - Facility Types and Temporary Storage Various Other Specifications, Standards, and related Requirements 5
Michael Malis FDA Guidance for Herpes Simplex Virus Types 1 and 2 Serological Assays US Food and Drug Administration (FDA) 0
B What are the Types of Quality Tools? Quality Tools, Improvement and Analysis 6
R Inspection types A, B AND C used in FMEA Preparation FMEA and Control Plans 3
M Design for Six Sigma to be applied for different types of Manufacturing Processes Six Sigma 1
R Different types of Design and Development - AS9100C Clause 7.3 AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 2
Q Different Types of Audits in Medical Device industry Misc. Quality Assurance and Business Systems Related Topics 9
N Report Content of 2 types of Calibration on the same equipment - Timer and Speed Test General Measurement Device and Calibration Topics 2
N Difference between different types of Benchtop Convection Ovens General Measurement Device and Calibration Topics 5
Q How should I Keep my various types of records .. ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
T Determination of UMDNS Code for various types of Contact Lens ISO 13485:2016 - Medical Device Quality Management Systems 4
Marc Three-Inch Device Detects 3,000 Types of Viruses and Bacteria World News 0
M Types of Yearly Quality Goals for all Manufacturing Associates Manufacturing and Related Processes 3
O Average Life Cycle Duration for a large number of medical equipment types Other Medical Device and Orthopedic Related Topics 2
E Calibration of Calipers, Mics, Height gauges - Recommended Gage Block Types General Measurement Device and Calibration Topics 7
C Creating a Micro QMS - 4 geographical sites and 3 types of core activities ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
M Definition P-Diagram - Types of Noise Factors - Information System Processes Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 12
P Determining Sample Size - Filling a bag with three different types of candy Inspection, Prints (Drawings), Testing, Sampling and Related Topics 31

Similar threads

Top Bottom