ISO 10993-7:2008/ Amd.1:2019 - Classification of special populations

akyt

Registered
#1
Hi everyone! Can you help me?

I have some doubts related to the implementation of Amendment 1 of the ISO 10993-7:2008 standard.

The amendment talks about new EO and ECH residual limits for products for special populations, such as premature neonates, neonates and children.
For example: for products with limited exposure (less than 24 hours), the limit for EO is 0.3 mg/Kg/day, and the limit for ECH is 0.64 mg/Kg/day.

We have in our portfolio medical devices classified as neonates, pediatric and infants.
So, how can I define a median body mass to establish the new limits of EO and ECH?
The amendment also establishes that the body mass used for each category of special patient population shall be justified and documented.

Another doubt: this amendment was published on 2019-12. What is the maximum period to adapt the company after this publication?

Thank you all.
 
Elsmar Forum Sponsor

planB

Trusted Information Resource
#2
akyt,

2 options for body-mass references for your patient population:

  • ISO 10993-17:2002, section 6.2.2, Devices specifically intended for use in neonates and children - quote:
TE calculations should be performed using body mass 3,5 kg for neonates and 10 kg for children as the human body mass for that device.
  • Statistical data, either from national institutions or from the WHO

Unless there is a published transition period (which is not for this amendment), there is no fixed time frame, until when regulators expect compliance. Typically, this may be 1/2 - 1 year after publication. For this amendment, at least in the EU, the contents of this amendment have practically already been expected by notified bodies since 2016, after the French authorities raised serious concerns about this standard in 2014.

HTH,

Gerhard
 
Thread starter Similar threads Forum Replies Date
I EO (Ethylene Oxide) Residuals - EN ISO 10993-7:2008 EU Medical Device Regulations 5
M EO (Ethylene Oxide) and ECH (Ethylene Chlorohydrin) Residual as per ISO 10993-7:2008 ISO 13485:2016 - Medical Device Quality Management Systems 15
B Implementation Schedule in EU for ISO 10993-7:2008 - Transition period? EU Medical Device Regulations 9
K Diagnostic X-ray devices - Applicability of Biocompatibility Testing per ISO 10993-1 Manufacturing and Related Processes 5
P European versions of standards - ISO 10993-1 and ISO 11607-1 EU Medical Device Regulations 6
S ISO 10993 Biocompatibility Evaluation - Electronic thermometer Other Medical Device Related Standards 3
P ISO 10993-1:2018 - When will the European equivalent become a Harmonized Standard? Other Medical Device Related Standards 13
I ISO 10993 Biocompatibility Requirements - manufacturing process chemicals Other Medical Device Related Standards 8
N Technical File Reviewer has requested more testing to ISO 10993 Other Medical Device Related Standards 10
T ISO 10993-7 - Ethylene oxide sterilization residues Other Medical Device Related Standards 1
planB ISO 10993-1:2018 has just been published Other Medical Device Related Standards 2
M Does ISO 10993 Apply to Packaging? (e.g. Travel Case) Other Medical Device Related Standards 4
K ISO 10993 Requirements For 510k - Substantial Equivalence Other US Medical Device Regulations 11
T Using Risk Management in ISO 10993 - Medical Device Accessory 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
P ISO 10993 - Sterile (Irradiation) Polypropylene Syringe Question Other Medical Device Related Standards 6
D Actual Definition of Non-Contact for ISO 10993 Other Medical Device Related Standards 1
R Biocompatibility - ISO 10993 and SVHC Requirements Other Medical Device Related Standards 4
S ISO 10993-1: External Communicating Device biocompatibility test requirements Other ISO and International Standards and European Regulations 4
S Selecting materials for implants to comply with ISO 10993 biocompatibility Other Medical Device Related Standards 4
T Plastic of an infusion pump enclosure and ISO 10993 ISO 13485:2016 - Medical Device Quality Management Systems 2
E Upcoming changes for ISO 10993 and IEC 60601 in South Korea Other Medical Device Regulations World-Wide 2
M FDA issues draft guidance to replace G95-1 (Application of ISO 10993) 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 0
B Verify GB/T 16886 is the same as ISO 10993 US Food and Drug Administration (FDA) 5
B New ISO 10993-12 - Consistency of Extraction Conditions through different Assays Other ISO and International Standards and European Regulations 1
S Suppliers of ISO 10993 compliant Material for Skin Contact Other ISO and International Standards and European Regulations 3
M ISO 10993 - Repeat tests necessary if colour changes slightly? Other Medical Device Related Standards 11
M Pre-Selecting Materials for ISO 10993-1 Biocompatibility Compliance Other ISO and International Standards and European Regulations 5
F ISO 10993-10 - Removed from List of Harmonized Standards Other Medical Device Related Standards 4
S ISO 10993 Cytotox Testing - Direct Contact rather than Extractables Other Medical Device Related Standards 4
E Meeting ISO 10993-1 2009 Material Risk Assessment Requirements Other Medical Device Related Standards 13
M ISO 10993 Labs which can test Cytotoxicity, Sensitizaton and Irritation Other Medical Device Related Standards 10
M ISO 10993 for Fabric based Electrode - Finding already FDA Approved Materials Other Medical Device Related Standards 11
J Biological Evaluation requirements per ISO 10993 - Medical Device Testing ISO 13485:2016 - Medical Device Quality Management Systems 2
A Claiming Biocompatibility without ISO 10993-1 Other Medical Device Related Standards 19
J ISO 10993 (Biological Compatibility) Approved Materials US Food and Drug Administration (FDA) 23
T ISO 10993-10: 2002 vs 2010 version - What are the Major Changes? ISO 13485:2016 - Medical Device Quality Management Systems 2
W ISO 10993 (Biological Evaluation of Medical Devices) for Suppliers Other ISO and International Standards and European Regulations 8
D Does anyone know of a biocompatible ABS tested & certified to ISO 10993-1 Other Medical Device Related Standards 5
W ISO 10993 - Replacing Sensitization Test with Systemic Toxicity Test? Other Medical Device Related Standards 4
I ISO 10993-10:2010 Guidance Document for Irritation and Sensitization Test - Changes ISO 13485:2016 - Medical Device Quality Management Systems 3
I ISO 10993-1:2009 Sensitization (Initial Evaluation Test) vs. USP Other Medical Device Related Standards 3
B What ISO 10993 considers Non-Invasive vs. Invasive MDD 93/42/EEC EU Medical Device Regulations 3
C Differences between the biocompatibility standards ISO 7405 and ISO 10993 Other Medical Device Related Standards 2
R What the difference in ISO 10993-11:2006 and 2009? Other Medical Device Related Standards 17
R Extent of Recognition of ISO 10993-1 US Food and Drug Administration (FDA) 5
M Biocompatibility of Medical Devices (ISO 10993 vs Japan requirement) Japan Medical Device Regulations 1
J ISO 10993: Biocompatibility and Use of Textile Materials for Skin Contact Devices Other Medical Device Related Standards 1
D Cytotoxicity testing to ISO 10993-5 results - Is 1/ mild a pass or fail? Other Medical Device Related Standards 7
R ISO 10993-1:2009 incorporating Risk Management published by ISO ISO 13485:2016 - Medical Device Quality Management Systems 1
M ISO 10993-5:2009 vs. ISO 10993-5:2003 differences - Cytotoxicity Testing Other Medical Device Related Standards 7
Similar threads


















































Top Bottom