Sterilisation Services Pvt. Ltd.

Gap analysis for the ISO 11135:2007 Part 1 / ISO 11135:2008 Part 2 & ISO 11135:2014:
The compliant column below provides:
Yes -The clauses are similar/same.
Yes, but - the clause are similar but for some minor changes.
No, but - The clauses are new and need implementation
No - The clauses are obsolete

ISO 11135:2007 Part -1. &

ISO 11135 :2008
Part II
Clause
No.

ISO
11135:2014

Currently in
place

Contents

Clause
No.

Contents

Foreword

Foreword

Introduction
Scope

Introduction
1
1.1
1.2

Compliant

Comments / New
additions

Yes

Yes

Yes

Yes

Yes
Yes, but

Yes
Yes

Sterilisation Services Pvt. Ltd.

Scope
Inclusions.
Exclusions.

Revision
Needed.

No
-

In functional content, the scope of the standard remains

largely unchanged. The scope now contains categories of
"inclusion" and "exclusion" for delineating the scope of the
standard. As in ISO 11135-1:2007, the standard does not:

Apply to inactivation of spongiform encephalopathies.

Specify the requirements for designating a medical

No
No
Where
ever
appropriate
to
mention
in
the
proposed validation
protocols / reports

device as sterile.

Specify a quality management system.

Specify occupational safety requirements for operation

of EtO equipment.

Pertain to the direct injection of EtO into

packages/flexible chambers.

Normative
references

Normative references

Yes, but

Yes

Normative references are largely unchanged. References

to the biocompatibility standard, ISO 10993-1, have
been deleted.
ISO 14161, Sterilization of health care products
Biological indicators Guidance for the selection, use
and interpretation of results&

Terms and
definitions

Terms and definitions

Yes, but

Yes

ISO 14937:2000, Sterilization of health care products

General requirements for characterization of a
sterilizing agent and the development, validation and
routine control of a sterilization process for medical
devices.
New terms and definitions have been added to the
standard, which were previously common practice but
undefined. New terms include virgin material (material that
has not been previously used or subjected to processing

Where
ever
appropriate
to
mention
in
the
proposed validation
protocols / reports

Where
ever
appropriate
to
mention
in
the
proposed validation

Sterilisation Services Pvt. Ltd.

Prepared by: Yogesh Borkar
Designation: Manager Quality Assurance

Signature & Date: