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GLOBAL JOURNAL OF ADVANCED ENGINEERING TECHNOLOGIES AND

SCIENCES RISK MANAGEMENT AND STERILIZATION PROCESS IN MEDICAL
DEVICE INDUSTRY

Research · May 2021

DOI: 10.13140/RG.2.2.32657.15205

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GLOBAL JOURNAL OF ADVANCED ENGINEERING TECHNOLOGIES AND
SCIENCES
RISK MANAGEMENT AND STERILIZATION PROCESS IN MEDICAL DEVICE
INDUSTRY
Muhammad Sadeque*1 & Anand Patel2
*1&2
Mechanical Engineer, HCL America Inc, USA

ABSTRACT
FMEA is a structured method to study a design or process that anticipates and minimizes unwanted performance or
unexpected failures. FMEA is primarily a qualitative technique and is considered a “bottom-up” technique, as
individual aspects of risk are analyzed separately and combined. Reusable devices are contaminated with
microorganisms after the use of medical devices. To overcome these risks, “reprocessing” is carried out. As per the
manufacturer’s instructions, all medical devices must be reprocessed before use. In this paper, we will describe the
FMEA, Risk management process, and different types of sterilization and cleaning steps. It will give an overview of
medical device remediation of risk management and sterilization process.

KEYWORDS: FMEA, PFMEA, RPN, PMSR, Implant, Sterilization, Contaminants, Reprocessing, Cleaning,
Disinfection.

Nomenclature

FMEA Failure mode effect analysis

PFMEA Process failure mode effect analysis

RPN Risk Priority Number

Lay Person Patient/Caregiver

PMSR Post market surveillance report

SAL Sterility Assurance Level

ETO Ethylene Oxide

PQ Process Qualification

IFU Instruction of Use

Definition of terms:

Terms Definition
Sterilization the validated process used to render a product free
from viable microorganisms [14]
Reprocessing activities such as cleaning, disinfection, and
sterilization at a health care facility for re-usable
devices

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Cleaning removal of contaminants to the extent necessary for
further processing or for intended use [14]
Contaminant/Residue biological, chemical, or physical substance on the
device that can impair the safety or the performance
of the implant [15]
Re-usable Medical Device medical device designated or intended by the
manufacturer as suitable for processing and reuse [14]
Sterile free from viable microorganisms [14]
Equivalence Product is compared to master products in terms of
different challenge features
Disinfection the process to reduce the number of viable
microorganisms to a level previously specified as
being appropriate for a defined purpose [18]
Single-Use Device Provide sterile and use on a patient for a single time
and then disposed
Product Family group or subgroup of the product characterized by
similar attributes determined to be equivalent for
evaluation and processing purposes [14]
Sterility Assurance Level probability of a single viable microorganism
occurring on an item after sterilization [14]
Process Qualification process of obtaining and documenting evidence that
the equipment, as installed and operated in
accordance with operational procedures, consistently
performs in accordance with predetermined criteria
and thereby yields product meeting its specification
[16]

Instruction of Use information provided by the legal manufacturer for

the reprocessing of the device.

INTRODUCTION
A FMEA provides the design engineer, reliability engineer and others with a Systematic process to analyze systems,
subsystems, products with all possible hazards and harms. After that, it will places a probability that the failure
mode/hazard will occur and what causes &effect this failure has on the rest of the systems. There are four types of
FMEAs in general:
 Design FMEA
 Process FMEA
 System FMEA
 Functional FMEA

Design FMEAs are performed on the product at the design level. Design FMEAs are used to analyze a design and to
identify and assess the risk of failures and their impact on the next level of assembly. There are nemourids benefit of
developing design DFMEA:
a. Preventive measures can be planned
b. Product Traceability
c. Easy going audit Perform

Process FMEAs are performed on the manufacturing process. Process FMEAs are used to analyze a process and
identify all possible risk of failures. Process FMEAs permit preventive measures, can be planned maintenance
procedure effectively, and helpful to identify nonconformity product. Developing PFMEA has some merits:

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a. Less scrap in Production
b. Less rework in production
c. Optimal Production Cost
d. Product traceability
f. Strong inventory control

System FMEAs are composed of part level FMEAs such as design FMEAs for individual components. It is considered
a detail observation in each components level and all possible causes; effects are being listed.

Functional FMEAs focus on the performance of the component or device being analyzed. This type of FMEA is also
known as a “Black Box” FMEA. FMEA focuses on the performance of the intend part or devices.

FMEA is a detailed analysis of a system down to the component level. Once all the items are classified as to the
hazard/failure, causes of failure, effect of failure and the probability that the failure will occur then it will be converted
to quantitative value called RPN. It is a risk priority number and goal are to reduce this RPN value lower by taking
extra effort from design, engineering, manufacturing, and testing point of view. Some sort of cleaning or field test
result, additional testing may use to reduce RPN value and mitigate overall risk.

FMEA PROCESS STEPS

Design FMEA process:
Design FMEA consist following sections:
Function, Failure mode, Severity, Potential cause, effect Occurrence, Occurrence number, RPN, Preliminary
outcome, Corrective actions & Outcome.

Table 1: Typical sample Design DFMEA [1]

Function Failure Potential Severity Cause S O R Outc Responsi Action S O R Final
mode Effect class E C P ome bility taken E C P Outcome
V C N and V C N
target
Accepted

Accepted
Implant Implant Patient Infection Poor 8 2 16 N/a N/a 8 2 16
must broken Serious Design
sustain in ill.
load.

Function: Need to provide a summary of the intended use and function of the device, component, or sub-system. For
an example, screw is considering an implant and screw must adequately secure to bone and maintain integrity to
withstand the forces. It must withstand all kind of shocks and anatomic fatigue loads. This is the intended use of screw
in medical device term.

Cause of failure: It is basically potential failure modes. We must list how the part, assembly, sub-assembly, or
components/device could potentially fail. Identify known or foreseeable hazard arising from design and end user point
of view. For an example, Bone screw or rod are used to make correction scoliosis issue on spine side. Screw or rod
can fail during surgical time due to poor design, materials defect, or mating issues. These are the failure modes and
need to be addressed on DFMEA.

Severity: severity is to link with harm. Each harm in the harms list has a severity score as well as detail explanation
as to why it was scored as such. Different organization has different benchmark and must follow company own
protocol. It can be ranged from 1-9. Higher number consider higher risk.

Occurrence: Occurrence rate calculation includes harm link to all intended user profile. It includes surgeon, doctor,
patients, nurse, technician, and all end users. Occurrence calculation can be determined by using below table.

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Sometime post market data, Engineers comments and review note play vital roles to determine occurrence calculation
[1,2,4].

Table 2: occurrence calculation [2]

Category Occurrence Probability Rating

Very High 1 in 10 ≥10% 10

1 in 50 2%≤Occurrence<10% 9
High level 1 in 100 ≥1% 8
1 in 500 0.2%≤Occurrence<1% 7
Moderate 1 in 1000 ≥0.1% 6
1 in 2000 0.05%≤Occurrence<0.1% 5
1 in 5000 0.02% 4
Low 1 in 100,000 ≥0.001% 3
1 in 1,00,0000 0.0001%≤Occurrence<0.001% 2

Very low No defect -------- 1

(Table source: Bill Wortman (Eleventh Edition, 2018) CQE Primer, Quality Council of Indiana)

RPN: It is product of the (S) and occurrence(O) ratings. Sometime detection(D) term is being used. Then RPN is
simple of product of severity, occurrence, and detection. Since each scale (S, O, D) ranges from 1 to 10.
Min(RPN)=1and max(RPN)=1000.The RPN is used to rank order the concerns in the design[1].

Outcome: Different organization has different approach to represent outcome. In medical device industry, outcome
represent “acceptable” risk is one category. Means, risk have been reduced to the lowest possible and no further action
is required. Some risks are high and need to do further investigation and detail risk mitigation plan is required.
Organization’s management need to be involved to determine, establish, and maintain risk protocol and procedures to
mitigate risks.

Recommended actions: All risk, regardless of the level, need to be reduced as far as possible. For RPNS that are
unacceptable, high, and identified by the cross functional team, recommend action need to be developed. The intent
of any action is to reduce the severity and or occurrence ratings by some type of risk mitigation plan. For an example-
Screw and rod to be secured and locked by each other to prevent any failure. Failure mode found the screw broken
and further investigation reveal that- the alignment and detail procedures of the closure mechanism of screws and
provided a solution to minimize cross threading and breaking. Detail analysis, complaint study and data from the
single counterpart indicates that it was difficult to cross thread and break. It could be happened due to the lack of
knowledge of using implants and instruments by the experts. Workshops, in-house instructions are excellent materials
to keep expert knowledge update.

Area responsibility: Identify & list individual responsibility for completing the recommended action. In medical
device, typically Quality, Mechanical, R&D are responsible for design DFMEA Purpose. Manufacturing Engineers
are responsible for any kind of change & improvement occurs in Process FMEA.

Action taken: Need to provide a brief justification of actual action taken and referring to supporting documentation.
For broken off the screw implant an example of detail action can be expressed like below rationale:
“Screw materials found to be appropriate. Fatigue test has been performed to see any kind of internal failure and
satisfied by the outcome.”

Final outcome- We need to update these categories and plug the new RPN after providing enough design verification,
validation activities have been completed to ensure an acceptable level of risk. Before entering final RPN, all potential
risk to ensure as low as possible. Decision of all risks are low base on providing enough evidence of design verification,
validation, testing protocol and management approval [1,2,3,5].

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Process FMEA
Process PFMEA occurrence calculation and severity are the same as described above. Process PFMEA describe
process related failure, hazard, cause, and effect of failures. In medical device industry we can take one example for
driver manufacturing steps where below flow diagram has been developed. We will describe getting Raw materials
hazard, cause& effect as an example of process PFMEA.
Process Flow:
Raw material-----Cleaning method-----Machining Process---De-bulk process---Heat treatment-----Passivation----
Laser etch------Inspection per ASL guideline-----Final inspection----Packaging----Shipping.
We can consider getting raw material is a first process.
Possible Potential Failure Mode:
1. Incorrect batch of raw material
2. Incorrect material specifications

Potential Effect of Failure:

1. Return materials
2. Production delay

Potential Cause of Failure:

1. Supplier error
2. Poor communication

Severity and occurrence calculation: Severity conssits1-9 ranges from Harm table. Higher severity considers higher
risk. Each company follow their own harm table. If there is a Raw materials scarcity for example then it could end up
delay production, means-Patient life matter. It can be considering in higher risk and mark as”9”. Detection can be
calculated by using table 3[1].

Table 3: process fmea detection criteria: [1]

Some organization use detection table to represent total RPN value. Detection sample table is given below.
Category Criteria Probability Rating
Failure is certain to be happened No know control that detect 50%-60% 10
failure
30%-49% 9

High, failure occurs periodically Control detects failure mode 10%-20% 8

5%-9% 7

Moderate Moderate control failure 2%-4% 6

mode

1% 5

0.5% 4

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Relatively low Low control failure mode 0.05% 3

0.005% 2

No failure Failure almost impossible 0.0005% 1

(Table Source: Sarah E. Burke, Rachel T. Silvestrini, The Certified Quality Engineer Handbook, Fourth edition)
RPN calculation: RPN is the product of Severity, Detection, and occurrence. Need to determine whether fall under
accepted range or do need to do further investigation.

Table 4: sample pfmea [1]

01/01/20
Customer

PFMEA

Medical device Manufacturing Company

date

Supplier name: XXXXX

Part# Driver PFMEA A
rev
2 Rev XXXX Perform by:
Drawing#

date Process Quality Engineer

SL# Function Failure Potential S Potential D Re- Action O D Outco

RPN

RPN
OCC

Mode Effect E Cause E command taken C E me

SEV
V T ed action C T

1 Getting Raw Wrong Process 9 Wrong 2 3 54 See N/A 9 2 3 54 Accept

material Material delay supplier material
spec

2 Clean Part not Rework 8 Inadequate 2 3 48 See N/A 8 2 3 48 Accept

clean machine Procedure

3 Heat Treat Inadequate Production 9 Furnace 1 4 36 Heat N/A 9 1 4 36 Accept

finish delay issue treat#
XYZ

As we discussed of two FMEA, we found outcome “accepted”. Some failure and occurrence could force to move
further investigation and need to reduce risk as much as possible. Some sorts of mechanical testing, fatigue test or
improvement of materials lead to reduce failure. Manufacturing process improvement, improvement of inspection
methods, applying lean, six sigma, Kaizen tools could lead up improvement of Process FMEA steps [13].

DFMEA/PFMEA LOGIC
Basic decision flow chart for DFMEA/PFMEA structure has been shown in below.

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Flow Chart –DFMEA/PFMEA

Does DFMEA need to update?

Yes No

Provide Function No update is required for Occurrence,

Severity Calculation
Provide Potential failure mode

Identify Severity

Calculate Occurrence from Occurrence Table

OCC, Severity rationale Clear Justification how occurrence, Severity

is being calculated

Cause & Effect of failures

Calculate RPN, Outcomes and action to reduce

initial RPN

Fig 1: DFMEA/PFMEA Flow Chart

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RISK MANAGEMENT TOOL

Many Quality professionals have been trained in the regular use of risk management tools, The FDA guidance
document provides a list of risk management tools to assess and manage risks. Some of the tools are listed below [2]:

a) Flow chart/Block Diagram

b) Check sheets or list
c) Failure mode Effects and criticality analysis (FMECA)
d) Fault Tree/decision Tree analysis (FTA)
e) Hazard Analysis and critical control Points (HACCP)

Risk Management Continuous Process

Plan: Need to transfer risk information into decisions and actions. Each single activity needs to be recorded. Action’s
plan should be realistic and achievable.

Track: Monitor the risk indicators and action taken throughout the activity. If anything, risk identified during design
review time, designer and all stakeholders should agree and need to provide farm timeline to track the risk till mitigate.
Control: Adjust for deviations from planned action.
Mitigate: Reduce the impact of any unforeseen event. In medical device industry, risk mitigation is quite challenging.
If it is concern of strength and stability then tensile, fatigue test needs to be conducted. Further communications are
required to involve of cross functional team until risk has been fully mitigated.

Primary goal of risk control is to maintain the level of risk at or below an acceptable level and reduce risk low as much
as possible. This determination should be made by stake holders and should involve the risk management team.
Documentation is an important part of the risk management process. Risk plan should be in details & realistic. Plan
should review in periodically and close all actions within the time frame. If new risk identify, should identify its origin
and proper documentation is required. In medical device industry more frequently risk assessment and update are
required. Sometime audit flag forced to do update risk documents in an unplan situation. Control and monitoring risk
could be determined whether current risk plan and process are enough or not. Additionally, it is important to determine
whether risk treatments, hazards, harm etc. are effective or not and can be determine by additional testing, auditing
phase [1,2]

STERILIZATION STRATEGY
The sterilization strategy includes requirements for device sterilization, reprocessing evaluation which includes
cleaning, disinfection, and sterilization at a health facility, and cleaning validation for removal of manufacturing
residues which are listed in the Sterilization Section of the Design Requirements Matrix (DRM). The strategy is based
on the requirements from the applicable harmonized ISO standards for sterilization of medical devices.
Based on the device category sterilization strategy needs to be established as mentioned in Figure 2:

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Device

Microbiological Chemical/Particulate
Requirement Requirement

Sterile Device Non- Sterile Device Cleaning Validation at

Manufacturing Site for Removal of
Manufacturing Residue

Reprocessing Evaluation
Steriliztion Validation at the Health Care
Facility

Fig 2: Sterilization Strategy Establishment

For new devices introduction, equivalence can be set by comparing with the master product or validated by
performance qualification. If the devices create a new worst-case when compared to the master product family or
change in the process flow, then revalidation needs to be performed.

MICROBIOLOGICAL REQUIREMENTS
The microbiological requirements are dependent on the intended use of the device. The product could be a
sterile/single-use device or a re-usable device.

Sterile Devices
This device is sterilized before reaching the health care facility for use. The commonly used sterilization method is
EO Sterilization and Radiation Sterilization. The sterilization process is performed as per the below ISO standards
along with the defined requirements.

Table 5: Sterilization Validation Requirements [16] [17][22]

Sterilization Method Standards Requirements
Radiation Sterilization  ISO 11137-1:2013,  ISO 11137-1 specifies
Sterilization of health care requirements for the
products – Radiation- Part 1: development, validation, and
Requirements for routine control of a radiation
development, validation, and sterilization process for
routine control of a medical devices.
sterilization process for
medical devices.  ISO 11137-2 specifies
methods for determining the

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 ISO 11137-2:2013, minimum dose needed to
Sterilization of health care achieve a specified
products – Radiation- Part 2: requirement for sterility and
Establishing the sterilization methods to substantiate the
dose. use of 25 kGy or 15 kGy as
the sterilization
dose to achieve a sterility
assurance level, SAL, of
10−6. This part of ISO 11137
also specifies methods of
sterilization dose audit used
to demonstrate the continued
effectiveness of the
sterilization dose.
Also, this part of ISO 11137
defines product families for
sterilization dose
establishment and
sterilization
dose audit.

Ethylene-Oxide (ETO)  EN ISO 11135-1 Sterilization  ISO 11135-1 specifies

Sterilization of health-care products - requirements for the
Ethylene oxide – Part 1: development, validation, and
Requirements for the routine control of an ethylene
development, validation, and oxide sterilization process for
routine control of a medical devices.
sterilization process for
medical devices

Non- Sterile Devices

These devices are re-usable and provided in non-sterile conditions with the validated reprocessing instructions
(including cleaning, disinfection, and/or sterilization) to be carried out before patient use.

ISO 17664 specifies requirements for the information to be provided by the medical device manufacturer for the
processing of a medical device that requires cleaning followed by disinfection and/or sterilization to ensure that the
device is safe and effective for its intended use. This includes information for processing prior to use or reuse of the
medical device. Rather, this document specifies requirements to assist manufacturers of medical devices in providing
detailed processing instructions that consist of the following activities, where applicable: [18]
a) Initial treatment at the point of use
b) Preparation before cleaning
c) Cleaning
d) Disinfection
e) Drying
f) Inspection and maintenance
g) Packaging
h) Sterilization
i) Storage
j) Transportation

CHEMICAL/PARTICULATE REQUIREMENTS
The requirements for the cleaning validation for the removal of manufacturing residues were derived from the
following.

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 CFR Title 21, Part 820, subpart G, Production and Process controls section 820.70, Clause h Manufacturing
Material defines the requirements. A manufacturing material could reasonably be expected to have an
adverse effect on product quality, the manufacturer shall establish and maintain procedures for the use and
removal of such manufacturing material to ensure that it is removed or limited to an amount that does not
adversely affect the device's quality. The removal or reduction of such manufacturing material shall be
documented [19].
 ISO10993-1 requires an assessment of risk for manufacturing processes and materials [20].
 EU MDR Regulation 2017/745 Section 10.1 and 10.2 [21].
o Devices shall be designed and manufactured in such a way as to ensure that the characteristics and
performance requirements
o Devices shall be designed, manufactured, and packaged in such a way as to minimize the risk
posed by contaminants and residues to patients
Cleaning process validation and the test methods which are based on a risk management process are performed as per
BS ISO 19227:2018[15].

CONCLUSION
The above content gives an overview of the risk assessment process and the sterilization strategy based on the device
category as per the requirements defined in the FMEA document. Reading this paper, one’s can get idea how to
develop a DFMEA/PFMEA and factors that need to be considered. However, we tried to provide some overview of
sterilization process that used in medical device industry for understanding of process, EU MDR requirements and
ISO standards.

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REFERENCE
[1] Sarah E. Burke, Rachel T. Silvestrini, The Certified Quality Engineer Handbook, Fourth edition
[2] Bill Wortman (Eleventh Edition, 2018) CQE Primer, Quality Council of Indiana
[3] Muhammad Sadeque, Saravana Kumar Balachandran, (2020), Overview of medical device processing,
Academic Press, Elsevier, pp177-188
[4] Frank, B,Marriott, P&A Warzzusen,C.(2016).CSQE Primer, Terre Haute,IN: Quality Council of Indiana
[5] FDA.(2006)”Guidance for industry:Q9 quality risk management ”International conference of Harmonization
of Technical Requirement for registration of Pharmaceuticals for human use(ICH)
[6] Hutching, G (2008,June).”risk management-The future of quality” Quality Digest”
[7] ISO/31000:2009.Risk Management-Principles and guidelines, Geneva: International Organization for
standardization
[8] MIL-STD-1629A(1980).Procedures for performing a failure mode, Effects and criticality Analysis.
Department of Defense, Government printing office
[9] Nikonova. V (2008,January-February),”applying ISO Management System standard to enterprise Risk
Management” ISO management system,8(1),10-14
[10] Stamatis, D.2003. Failure Mode and effect analysis: FMEA Theory to Execution.2nd,Mil-waukee, WI:ASQ
Quality press.
[11] NIST SP 500-204,(1992,July).High Integrity software standards and guidelines.
[12] RMA.(2011).Scenario Analysis: Part 1:Perespective and Principles. The Risk Management Association.
Downloaded February 25, 2015 from http://www.rmahq.org/
[13] Muhammad Sadeque, Viwek Vaidya, Workstation Optimization by Applying lean Manufacturing
Technique-A Production Case Study, IJESFT, Vol 6, Issue10,2020
[14] ISO 11139, Sterilization of health care products - Vocabulary of terms used in sterilization and related
equipment and process standards - First Edition.
[15] BSI BS ISO 19227, Implants for surgery — Cleanliness of orthopedic implants — General requirements.
[16] ISO 11137-1 Sterilization of health care products- Radiation - Part 1: Requirements for development,
validation and routine control of a sterilization process for medical devices.
[17] ISO 11137-2 Sterilization of health care products- Radiation- Part 2: Establishing the sterilization dose.
[18] ISO 17664: 2017 Processing of health care products - Information to be provided by the medical device
manufacturer for the processing of medical devices.
[19] https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=820.70
[20] ISO-10993-1 Biological evaluation of medical devices- Part 1: Evaluation and testing within a risk
management process
[21] https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R074
[22] EN ISO 11135-1 Sterilization of health-care products - Ethylene oxide – Part 1: Requirements for the
development, validation, and routine control of a sterilization process for medical devices

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