Biological evaluation plan and report

beltrans

Registered
Recently, on my company, we have started to develop a new medical device class IIb which presents a sensors that enter in contact with air flow, and a case that can be touched by the healthcare professional and we have several doubts.

We have never worked with biological evaluation plan, so we don’t completely understand the contents of this document. I was wondering if someone could share a template or an example.

Secondly, the case is manufactured externally with AISI 316 and white painting. Regarding the material, I think it is a completely studied material, and through literature justification to not perform cyto, irritation and sensitization would be sufficient. Regarding the painting I’m not so sure. Maybe chemical characterization would be needed in order to determine its chemical components, and in case there is some toxic substance over 0.01%, perform needed biocompatibility tests? Or maybe justifying a contact with the healthcare professional around 1 minute would be sufficiend to justify the low need to perform the tests?
 

planB

Super Moderator
beltrans,

refer to ISO 10993-1:2018, section B.2.2, "The biological evaluation plan" for guidance on putting together this kind of document - caveat in the same section "The biological evaluation plan should be drawn up by a knowledgeable and experienced team [...]".

Regarding the materials of your case: apart from the base materials, also consider
  • the manufacturing processes (including potential manufacturing residues) for the final case, and
  • whether the packaging configuration of your device in the case could affect the biocompatibility of your device
You are right on track: material characterization is the crucial first step in your biological evaluation. Bear in mind that there is no absolute standard threshold for non-toxicity (including no 0.01% threshold), but you may want to perform a risk-based toxicological assessment according to ISO 10993-17.

You seem to have a "transitory" exposure duration for your case according to ISO 10993-1, section 5.3.2. Bear in mind that this section also says "However, for products made with materials such as coatings or lubricants that could be left in contact with body tissues after the medical device is removed, it is possible that a more detailed biocompatibility assessment will be necessary."

HTH,
 

Mark Meer

Trusted Information Resource
...sensors that enter in contact with air flow, and a case that can be touched by the healthcare professional...

Although apparently not explicit in the standard, I was always under the impression that application of 10993 tests was with respect to patient-contacting materials. If the scope is expanded to any materials that are in contact with air-flow, or subject to limited contact by medical-professional operators, then the scope would always be pretty much any/all exposed materials.

For example, if an off-the-shelf Sony computer is supplied with the device, does the chassis or keys on the keyboard need to be shown to be biocompatible, because operators have to handle the computer to operate the device (not intended for patient contact)?
 

planB

Super Moderator
Mark,

you have a point, but unfortunately, ISO 10993-1:2018 is not entirely clear throughout the document, which type of contact is in scope of the standard. Section 1, ibid, contains this extended scope compared to the previous revison of the standard, where the "user" was not yet considered:
- the patient's body during intended use;
- the user’s body, if the medical device is intended for protection (e.g., surgical gloves, masks and others).

The flowchart Figure 1 contains only "patient contact", while section 5.2.2. a) contains this note:

Some medical devices used in either sterile or non-sterile environments include components that can come into contact with a user’s ungloved hands such as human interfaces for electronic equipment (e.g. computer keyboards, dials or buttons, touch screens, SD cards, USB sticks); housings for electronic monitors or programmers that can come into contact with any intact skin (e.g. electronic devices like cell phones, tablets); or components that can come into contact with a user’s gloved hand (e.g. catheter handles). If these types of components can be shown to be made from materials in common use for other consumer products with a similar nature of contact, no further biological evaluation is needed.

clearly indicating that also your example of (professional) use of an off-shelf computer is at least discussed as part of the standard.

In contrast, the FDA guidance on biocomaptibility contains this clear scope:
The scope of this document and accompanying attachments is limited to the biological evaluation of sterile and non-sterile medical devices that come into direct or indirect contact with the human body.

Bottom line in my view: from a risk management perspective, the lacking clarity with regards to patient/user and FDA's clear expectations to consider any body contact, it would be a prudent and conservative approach to include any potential intended body contact in a bicompatibility evaluation.

HTH,
 

Kuldeep Singh

Involved In Discussions
During an audit, we have debate on applicability of biocompatibility of parts which comes in contact with user. We give the reference of ISO 10993-1:2018 , scope of this standard only talks about patient , although this standard applicable on parts contact with user if the device is intended for protection such as surgical mask etc.

But Auditor didn't convince and give the reference of EU MDD 93/42/EEC , ER 7.1
7.1. The devices must be designed and manufactured in such a way as to guarantee the characteristics and performances referred to in Section I on the ‘General requirements’.
Particular attention must be paid to:
— the choice of materials used, particularly as regards toxicity and, where appropriate, flammability,
— the compatibility between the materials used and biological tissues, cells and body fluids, taking account of the intended purpose of the device,
— where appropriate, the results of biophysical or modelling research whose validity has been demonstrated beforehand.


Can anyone discuss this, is this bold line indicates that we should consider the biocompatibility for parts which comes in contact with user???

IMO , ER 7.1 didin't require biocompatibility for user contactable part. please guide if i am wrong.

your help will be appreciated.
 

mahima

Registered
Hi we are into manufacturing of medical devices and currently looking at CE approval for one of our devices. The device is a permanent implant that is used for cancer patients. The device is a stent and requires implantation in the body for long term purposes. We have never worked on BEP and BER in accordance with the ISO standards.

Could somebody please share a template or provide guidance on the same?
 

planB

Super Moderator
We have never worked on BEP and BER in accordance with the ISO standards.
Could somebody please share a template or provide guidance on the same?

Biocompatibility standard ISO 10993-1:2018 requires its application by experienced and knowledgeable professionals. Without previous exposure to this topic, I would strongly recommend to seek professional support; a shared template would probably not be sufficient.

HTH,
 

big boss

Starting to get Involved
dears can any one share biological evaluation SOPand biological evaluation plan and report template
 

Enternationalist

Involved In Discussions
Hi we are into manufacturing of medical devices and currently looking at CE approval for one of our devices. The device is a permanent implant that is used for cancer patients. The device is a stent and requires implantation in the body for long term purposes. We have never worked on BEP and BER in accordance with the ISO standards.

Could somebody please share a template or provide guidance on the same?
You're making a permanent implant for cancer patients and have zero experience in one of the basic elements of safety relevant to that device. Please step back and think seriously about that and your ethical obligations. Go pay a serious professional to help you.
 
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