,/.,/.,/.,/

1. Management of sterile stock
‫المعقم‬ ‫إدارةالمخزون‬

2. Introduction ‫مقدمة‬
• Sterile supplies should be handled and stored in a manner that maintains the integrity of packs and prevents
contamination from any source (dust, insects, sunlight, water, condensation, etc.).
•
‫مصدر‬ ‫أي‬ ‫من‬ ‫التلوث‬ ‫ويمنع‬ ‫الحزم‬ ‫سالمة‬ ‫نقائها‬ ‫على‬ ‫تحافظ‬ ‫بطريقة‬ ‫وتخزينها‬ ‫المعقمة‬ ‫اإلمدادات‬ ‫مع‬ ‫التعامل‬ ‫ينبغي‬
(
‫والحش‬ ‫الغبار‬
‫وأشعة‬ ‫رات‬
‫ذلك‬ ‫إلى‬ ‫وما‬ ‫والتكثيف‬ ‫والماء‬ ‫الشمس‬
.).
• The gradual introduction of new standards and evidence-based principles for the management of sterile
stock since the early
1990s has major implications for personnel who work in CSSDs and those who use sterile stock in their
practice.
•
‫ع‬ ‫كبيرة‬ ‫آثار‬ ‫لها‬ ‫التسعينات‬ ‫بداية‬ ‫منذ‬ ‫المعقم‬ ‫المخزون‬ ‫إلدارة‬ ‫األدلة‬ ‫على‬ ‫المبنية‬ ‫والمبادئ‬ ‫المعايير‬ ‫جديد‬ ‫التدريجي‬ ‫اإلدخال‬
‫الموظفين‬ ‫لى‬
‫في‬ ‫يعملون‬ ‫الذين‬
CSSDs
‫ممارساتهم‬ ‫في‬ ‫العقيمة‬ ‫األسهم‬ ‫يستخدمون‬ ‫الذين‬ ‫وأولئك‬
.
2

3. 4/28/24 Sterile storage & inventory control (ACST242) 3
Principle of event-related sterility ‫العقم‬ ‫مبدأ‬
‫المرتبط‬
‫بالحدث‬
• Event-related sterility (ERS) principle is now considered the Standard for sterilizing supply departments
CSSDs.
‫بالحدث‬ ‫المرتبط‬ ‫العقم‬
(
‫إرس‬
)
‫وحدات‬ ‫لتعقيم‬ ‫المعيار‬ ‫هو‬ ‫اآلن‬ ‫المبدأ‬ ‫يعتبر‬
CSSD
‫التوريد‬ ‫بإدارات‬ ‫الخاصة‬
.
• These standards suggest that contamination is related to features of the CSSD environment, as has been
the established principle.
‫بيئة‬ ‫بخصائص‬ ‫يرتبط‬ ‫التلوث‬ ‫أن‬ ‫إلى‬ ‫المعايير‬ ‫تشيرهذه‬
CSSD,
‫الثابت‬ ‫المبدأ‬ ‫كان‬ ‫كما‬
.
• Event-related sterility standards have applied a policy of 30-day stock
rotation and every item is contaminated after storage for 30 days, even if sterility barriers are still intact.
‫لمدة‬ ‫المخزون‬ ‫سياسة‬ ‫بالحدث‬ ‫المرتبطة‬ ‫العقم‬ ‫معايير‬ ‫طبقت‬
30
‫لمدة‬ ‫تخزينها‬ ‫بعد‬ ‫عنصرملوثة‬ ‫وكل‬ ‫التناوب‬ ً‫ا‬‫يوم‬
30
‫كانت‬ ‫لو‬ ‫حتى‬ ،‫يوما‬
‫سليمة‬ ‫تزال‬ ‫ال‬ ‫التعقيم‬ ‫حواجز‬
.

4. Sterile barrier system ‫حاجز‬ ‫نظام‬
‫معقم‬
• Sterile barrier system refers to minimum packaging that prevents contamination and helps to sterilize the
finished product.
‫النهائي‬ ‫المنتج‬ ‫تعقيم‬ ‫على‬ ‫ويساعد‬ ‫التلوث‬ ‫يمنع‬ ‫الذي‬ ‫والتغليف‬ ‫التعبئة‬ ‫من‬ ‫األدنى‬ ‫الحد‬ ‫الى‬ ‫يعود‬ ‫معقم‬ ‫حاجز‬ ‫نظام‬
.
• The system must guarantee sterility throughout the entire supply chain from production through to the
operation room.
‫العمليات‬ ‫غرفة‬ ‫وحتى‬ ‫اإلنتاج‬ ‫من‬ ً‫ا‬‫بدء‬ ‫بأكملها‬ ‫التوريد‬ ‫سلسلة‬ ‫أنحاء‬ ‫جميع‬ ‫في‬ ‫العقم‬ ‫النظام‬ ‫يضمن‬ ‫أن‬ ‫يجب‬
.
• A barrier system and constant control of the sterilization process,
together with the continuous monitoring of storage environment conditions, can provide a satisfactory
confidence level that stored sterile items are free from microbial contamination.
‫مرض‬ ‫توفر‬ ‫أن‬ ‫يمكن‬ ،‫التخزين‬ ‫بيئة‬ ‫لظروف‬ ‫المستمرة‬ ‫المراقبة‬ ‫مع‬ ‫جنب‬ ‫إلى‬ ‫جنبا‬ ،‫التعقيم‬ ‫لعملية‬ ‫المستمرة‬ ‫الحاجزوالمراقبة‬ ‫أنظام‬
‫ال‬ ‫مستوى‬ ‫ية‬
‫ثقة‬
‫الميكروبي‬ ‫التلوث‬ ‫من‬ ‫خالية‬ ‫المعقمة‬ ‫العناصر‬ ‫تكون‬ ‫أن‬ ‫تخزينها‬ ‫تم‬ ‫التي‬
.
4/28/24 Sterile storage & inventory control (ACST242) 4

5. 4/28/24 Sterile storage & inventory control (ACST242) 5

6. Sterile barrier system ‫معقم‬ ‫حاجز‬ ‫نظام‬
• A sterile barrier system is defined as a part of ISO 11607.
•
‫ايزو‬ ‫من‬ ‫كجزء‬ ‫تعريفه‬ ‫يتم‬ ‫معقم‬ ‫حاجز‬ ‫أنظام‬
11607
• ISO 11607 specifies the requirements and test methods for the
materials used in and the sterile barrier systems themselves, as well as preformed sterile barrier systems and
packaging systems that are required to maintain sterility until the point of use.
‫ايزو‬
11607
‫المع‬ ‫الحواجز‬ ‫أنظمة‬ ‫إلى‬ ‫باإلضافة‬ ،‫نفسها‬ ‫المعقمة‬ ‫الحواجز‬ ‫أنظمة‬ ‫في‬ ‫الموادالمستخدمة‬ ‫ل‬ ‫االختبار‬ ‫وطرق‬ ‫المتطلبات‬ ‫يحدد‬
‫مسبقة‬ ‫قمة‬
‫االستخدام‬ ‫نقطة‬ ‫حتى‬ ‫العقم‬ ‫على‬ ‫الحفاظ‬ ‫المطلوبة‬ ‫والتغليف‬ ‫التعبئة‬ ‫وأنظمة‬ ‫التشكيل‬
.
• A sterile barrier system minimizes the risk of entry of microorganisms and allows for an aseptic
presentation of the sterile contents.
•
‫معقمة‬ ‫محتويات‬ ‫لل‬ ‫العقيم‬ ‫العرض‬ ‫بدخول‬ ‫ويسمح‬ ‫الدقيقة‬ ‫الحية‬ ‫الكائنات‬ ‫دخول‬ ‫خطر‬ ‫من‬ ‫يقلل‬ ‫معقم‬ ‫حاجز‬ ‫أنظام‬
.
4/28/24 Sterile storage & inventory control (ACST242) 6

7. Sterility Assurance System ‫العقم‬ ‫ضمان‬ ‫نظام‬
• Sterility assurance is a level of confidence that a particular product that is supposed to be sterile is sterile and
describes the total of the arrangements made to ensure the sterility of products.
‫ضمان‬
‫العقم‬
‫هو‬
‫مستوى‬
‫من‬
‫الثقة‬
‫أن‬
ً‫ا‬‫منتج‬
ً‫ا‬‫معين‬
‫من‬
‫المفترض‬
‫أن‬
‫يكون‬
ً‫ا‬‫معقم‬
‫هو‬
‫معقم‬
‫ويصف‬
‫مجموع‬
‫الترتيبات‬
‫المتخذة‬
‫لضم‬
‫ان‬
‫عقم‬
‫المنتجات‬
.
• The first step in developing a sterility assurance program is to list each step, beginning at the point of use and
ending in sterile storage.
•
‫المعقم‬ ‫ًبالتخزين‬ ‫وانتهاء‬ ‫االستخدام‬ ‫نقطة‬ ‫من‬ ً‫ا‬‫بدء‬ ،‫خطوة‬ ‫كل‬ ‫إدراج‬ ‫يجب‬ ،‫العقم‬ ‫ضمان‬ ‫برنامج‬ ‫تطوير‬ ‫في‬ ‫األولى‬ ‫الخطوة‬
.
• Each step should be evaluated for methods to prevent contamination in the manufacturing process or
environments.
‫أوالبيئات‬ ‫التصنيع‬ ‫عملية‬ ‫التلوث‬ ‫من‬ ‫الوقاية‬ ‫طرق‬ ‫عن‬ ‫خطوة‬ ‫كل‬ ‫تقييم‬ ‫ينبغي‬
.
7

8. Sterility Assurance System ‫ضمان‬ ‫نظام‬
‫العقم‬
• Sterility assurance monitoring is a vital component of the overall sterilization quality assurance program.
‫تعد‬
‫مراقبة‬
‫ضمان‬
‫العقم‬
ً‫ا‬‫عنصر‬
ً‫ا‬‫حيوي‬
‫في‬
‫برنامج‬
‫ضمان‬
‫جودة‬
‫التعقيم‬
‫الشامل‬
.
• Sterility assurance products, including biological indicators (BI) and chemical indicators (CI) provide the
confidence that the sterilizer is functioning properly and cycle conditions are adequate to produce medical
devices that are ready and safe for patient use.
‫منتجات‬
‫ضمان‬
،‫العقم‬
‫بما‬
‫في‬
‫ذلك‬
‫المؤشرات‬
‫البيولوجية‬
(
‫بي‬
)
‫و‬
‫المؤشرات‬
‫الكيميائية‬
(
‫سي‬
.
‫آي‬
)
‫توفير‬
‫الثقة‬
‫بأن‬
‫جهاز‬
‫التعقيم‬
‫يع‬
‫مل‬
‫بشكل‬
‫صحيح‬
‫وأن‬
‫ظروف‬
‫الدورة‬
‫كافية‬
‫لإلنتاج‬
‫األجهزةالطبية‬
‫الجاهزة‬
‫واآلمنة‬
‫الستخدام‬
‫المريض‬
.
• Sterility assurance products are used for all sterilization modalities, including steam and ethylene oxide (EO).
‫يتم‬
‫استخدام‬
‫منتجات‬
‫ضمان‬
‫العقم‬
‫لجميع‬
‫طرق‬
،‫التعقيم‬
‫بمافي‬
‫ذلك‬
‫البخار‬
‫وأكسيد‬
‫اإليثيلين‬
(
EO.
8

9. Biological indicator
‫المؤشرالبيولوجي‬
Chemical indicator
‫المؤشرالكيميائي‬
4/28/24 Sterile storage & inventory control (ACST242) 9

10. Industry governing bodies ‫إدارة‬ ‫هيئات‬
‫الصناعة‬
• Various industry governing bodies, such as:
•
‫مثل‬ ،‫المختلفة‬ ‫الصناعة‬ ‫إدارة‬ ‫هيئات‬
:
• The Association for the Advancement of Medical Instrumentation
(AAMI), provides a range of guidance documents, recommendations, and standards for sterility assurance
monitoring.
‫الطبية‬ ‫األجهزة‬ ‫تطوير‬ ‫جمعية‬
.
، ‫العقم‬ ‫ضمان‬ ‫لمراقبة‬ ‫والمعايير‬ ‫والتوصيات‬ ‫اإلرشادية‬ ‫الوثائق‬ ‫من‬ ‫توفرمجموعة‬
)
AAMI)
• The American National Standards Institute (ANSI) is the United States
national standard body and all US standards and recommended practices with national recognition must
be accepted by ANSI.
‫المتحدة‬ ‫الواليات‬ ‫للمعاييرهي‬ ‫األمريكي‬ ‫الوطني‬ ‫المعهد‬
)
ANSI)
‫األمريكية‬ ‫المعايير‬ ‫وجميع‬ ‫الوطنية‬ ‫المعايير‬ ‫هيئة‬ ‫تكون‬ ‫يجبأن‬
‫قبل‬ ‫من‬ ‫مقبولة‬ ‫الوطني‬ ‫االعتراف‬ ‫مع‬ ‫بها‬ ‫الموصى‬ ‫والممارسات‬
ANSI.
4/28/24 10

11. Sterility Assurance level ‫ضمان‬ ‫مستوى‬
‫العقم‬
• A sterile medical device is free from all viable microorganisms.
‫للحياة‬ ‫القابلة‬ ‫الدقيقة‬ ‫الحية‬ ‫الكائنات‬ ‫جميع‬ ‫من‬ ً‫ا‬‫خالي‬ ‫المعقم‬ ‫الطبي‬ ‫الجهاز‬ ‫يكون‬
.
• The sterility of a product is defined by the probability of a single viable microorganism occurring on an item after
sterilization.
‫التعقيم‬ ‫بعد‬ ‫السلعة‬ ‫على‬ ‫موجود‬ ‫دقيق‬ ‫حي‬ ‫كائن‬ ‫واحد‬ ‫منتج‬ ‫وجود‬ ‫احتمالية‬ ‫خالل‬ ‫من‬ ‫المنتج‬ ‫عقم‬ ‫تحديد‬ ‫يتم‬
.
• This probability is referred to as a sterility assurance level (SAL).
•
‫العقم‬ ‫ضمان‬ ‫بمستوى‬ ‫االحتمال‬ ‫هذا‬ ‫ويشارإلى‬
(
SAL.
• The SAL is normally expressed as 10n and is a quantitative value used to assure sterility assurance.
‫عن‬ ‫التعبير‬ ‫يتم‬
SAL
‫ًكـ‬ ‫عادة‬
10
‫العقم‬ ‫ضمان‬ ‫لضمان‬ ‫مستخدمة‬ ‫كمية‬ ‫قيمة‬ ‫وهي‬ ‫ن‬
.
4/28/24 11
A SAL of 10-6 means that there is less than or equal to one chance in a million that
a single viable microorganism is present on a sterilized item
‫من‬ ‫سال‬
10
-
6
‫المعقم‬ ‫العنصر‬ ‫على‬ ‫واحد‬ ‫دقيق‬ ‫حي‬ ‫كائن‬ ‫لوجود‬ ‫المليون‬ ‫في‬ ً‫ا‬‫واحد‬ ‫تساوي‬ ‫أو‬ ‫من‬ ‫أقل‬ ‫فرصة‬ ‫هناك‬ ‫أن‬ ‫يعني‬

12. • A lower SAL confirms a greater assurance of sterility.
‫انخفاض‬ ‫يؤكد‬
SAL
‫للعقم‬ ‫أكبر‬ ‫ضمان‬ ‫على‬
• While 100% assurance of sterility can never be reached, the SAL for a sterile medical device should be reduced
to low numbers.
‫بنسبة‬ ‫العقم‬ ‫ضمان‬ ‫إلى‬ ‫الوصول‬ ً‫ا‬‫أبد‬ ‫يمكن‬ ‫ال‬ ‫أنه‬ ‫حين‬ ‫في‬
100
،
%
‫فإن‬
SAL
‫منخفضة‬ ‫أعداد‬ ‫إلى‬ ‫الطبية‬ ‫األجهزة‬ ‫تقليل‬ ‫يجب‬ ‫للعقم‬
.
4/28/24 Sterile storage & inventory control (ACST242) 12

13. Event-related sterility assurance ‫العقم‬ ‫ضمان‬
‫المتعلق‬
‫بالحدث‬
• Event-related sterility assurance is any event that compromises the integrity of the barrier
enclosing the sterilized material.
‫المعقمة‬ ‫بالمادة‬ ‫المحيط‬ ‫الحاجز‬ ‫بسالمة‬ ‫يضر‬ ‫حدث‬ ‫أي‬ ‫هو‬ ‫بالحدث‬ ‫المتعلق‬ ‫العقم‬ ‫ضمان‬
.
• Events that may occur just after sterilization, during transport, and storage (including repeated
handling of the packaged material), leading to breaches, punctures, holes, crushing, etc.
•
‫التعقيم‬ ‫بعد‬ ‫فقط‬ ‫تحدث‬ ‫قد‬ ‫التي‬ ‫األحداث‬
,
‫والتخزين‬ ‫النقل‬ ‫أثناء‬
(
‫الم‬ ‫المواد‬ ‫مع‬ ‫المتكرر‬ ‫التعامل‬ ‫ذلك‬ ‫في‬ ‫بما‬
‫عبأة‬
)
‫إلى‬ ‫يؤدي‬ ،
‫االنتهاكات‬
,
‫ثقوب‬
,
‫الخ‬ ،‫سحق‬ ،‫الثقوب‬
• These events include materials that are sterilized in-house or those that are purchased pre-
packaged and pre-sterilized.
‫مسبق‬ ‫ومعقمة‬ ‫مغلفة‬ ‫شراؤها‬ ‫يتم‬ ‫التي‬ ‫تلك‬ ‫أو‬ ‫الشركة‬ ‫داخل‬ ‫تعقيمها‬ ‫يتم‬ ‫التي‬ ‫المواد‬ ‫األحداث‬ ‫هذه‬ ‫تشمل‬
13

14. Factors affecting sterility ‫المؤثرة‬ ‫العوامل‬
‫على‬
‫العقم‬
• Many factors should be considered when determining how
long these materials remain sterile (e.g., time limit, hold time,
expiration, etc.).
‫معقم‬ ‫المواد‬ ‫هذه‬ ‫بقاء‬ ‫مدة‬ ‫تحديد‬ ‫عند‬ ‫االعتبار‬ ‫في‬ ‫العوامل‬ ‫من‬ ‫العديد‬ ‫أخذ‬ ‫يجب‬
(
‫على‬
‫ذلك‬ ‫إلى‬ ‫وما‬ ،‫الصالحية‬ ‫وانتهاء‬ ،‫االنتظار‬ ‫ووقت‬ ،‫الزمني‬ ‫الحد‬ ،‫المثال‬ ‫سبيل‬
. ).
• Factors should be considered: •
‫العوامل‬ ‫في‬ ‫النظر‬ ‫ينبغي‬
:
• Type of packaging material •
‫التغليف‬ ‫مادة‬ ‫نوع‬
• Handling of sterile items •
‫العناصر‬ ‫مع‬ ‫التعامل‬
‫المعقمة‬
• Storage conditions ‫التخزين‬ ‫شروط‬
14

15. Packaging material ‫التعبئة‬ ‫مواد‬
‫والتغليف‬
• Extreme physical conditions that affect packing materials include
temperature, pressure, radiation, etc.
•
‫الظروف‬
‫المادية‬
‫القاسية‬
‫ذلك‬
‫يؤثر‬
‫تشمل‬
‫مواد‬
‫التعبئة‬
‫درجة‬
،‫الحرارة‬
‫الضغط‬
‫واإلشعاع‬
‫وما‬
‫إلى‬
‫ذلك‬
• Consideration should be given to not only the packaging material but
also to the item itself to be sterilized.
‫نفسها‬ ‫البند‬ ‫لهذا‬ ‫أيضا‬ ‫ولكن‬ ‫والتغليف‬ ‫التعبئة‬ ‫مادة‬ ‫فقط‬ ‫ليس‬ ‫في‬ ‫النظر‬ ‫ينبغي‬
‫تعقيمها‬ ‫ليتم‬
• Detail the requirements for inspecting sterilized materials after
sterilization for any ruptures of packaging integrity.
‫ال‬ ‫سالمة‬ ‫في‬ ‫تمزق‬ ‫أي‬ ‫ل‬ ‫التعقيم‬ ‫بعد‬ ‫موادمعقمة‬ ‫التفتيش‬ ‫متطلبات‬ ‫تفاصيل‬
‫والتغليف‬ ‫تعبئة‬
.
15

16. Evaluation of Packaging Material ‫مواد‬ ‫تقييم‬
‫التعبئة‬
‫والتغليف‬
• Packaging materials must be compatible with the method of sterilization
to ensure that not only are they not degraded (either immediately or long
term), but also that they permit sterilization of the target item.
‫ليس‬ ‫أنها‬ ‫من‬ ‫للتأكد‬ ‫التعقيم‬ ‫طريقة‬ ‫مع‬ ‫متوافقة‬ ‫والتغليف‬ ‫التعبئة‬ ‫مواد‬ ‫تكون‬ ‫أن‬ ‫يجب‬
‫فقط‬ ‫ت‬
‫التتدهور‬
(
‫الطويل‬ ‫المدى‬ ‫على‬ ‫أو‬ ‫الفور‬ ‫على‬ ‫إما‬
)
‫ا‬ ‫العنصر‬ ‫بتعقيم‬ ً‫ا‬‫أيض‬ ‫تسمح‬ ‫ولكنها‬ ،
‫لمستهدف‬
.
• For example, packaging materials for steam sterilization
should provide adequate air removal, permit steam penetration and direct
contact with the item’s surfaces, and permit adequate drying.
‫كا‬ ‫إزالة‬ ‫يوفر‬ ‫أن‬ ‫يجب‬ ‫بالبخار‬ ‫للتعقيم‬ ‫والتغليف‬ ‫التعبئة‬ ‫مواد‬ ،‫المثال‬ ‫سبيل‬ ‫على‬
‫ويسمح‬ ،‫للهواء‬ ‫فية‬
‫المناسب‬ ‫بالتجفيف‬ ‫والسماح‬ ،‫السلعة‬ ‫بأسطح‬ ‫المباشر‬ ‫واالتصال‬ ‫البخار‬ ‫باختراق‬
.
16

17. Wrapping materials ‫موادالتغليف‬
• Describe the size of the wrapping material that is adequate for enwrapping the
item, including techniques for sealing the package.
‫العبوة‬ ‫إغالق‬ ‫تقنيات‬ ‫ذلك‬ ‫في‬ ‫بما‬ ،‫العنصر‬ ‫لتغليف‬ ‫كاف‬ ‫هذا‬ ‫التغليف‬ ‫مادة‬ ‫حجم‬ ‫وصف‬
.
• The item should be wrapped securely to prevent gapping, billowing, and air pockets
from forming conditions that may adversely affect the sterilization process.
‫فجوة‬ ‫لمنع‬ ‫آمن‬ ‫بشكل‬ ‫البند‬ ‫هذا‬ ‫مغلفة‬ ‫تكون‬ ‫أن‬ ‫يجب‬
,
‫ال‬ ‫الظروف‬ ‫تكوين‬ ‫من‬ ‫تذاكرطيران‬ ‫و‬ ،‫تتصاعد‬
‫تؤثر‬ ‫قد‬ ‫تي‬
‫التعقيم‬ ‫عملية‬ ‫ًعلى‬ ‫سلبا‬
.
• Sequential wrapping using two barrier-type wrappers is a common technique
employed to provide an additional barrier to microbial contamination.
‫لتوفير‬ ‫تستخدم‬ ‫شائعة‬ ‫تقنية‬ ‫أ‬ ‫الحاجز‬ ‫النوع‬ ‫من‬ ‫غالفين‬ ‫باستخدام‬ ‫المتسلسل‬ ‫التغليف‬ ‫يعد‬
‫للتلوث‬ ‫إضافي‬ ‫حاجز‬
‫الميكروبي‬
.
17

18. Rigid container inspection ‫الحاويات‬ ‫فحص‬
‫الصلبة‬
• Healthcare personnel bear the ultimate responsibility of ensuring
that a packaging system, including a rigid sterilization containers
system, is suitable for sterilization processing and sterility
maintenance.
•
‫التعبئة‬ ‫نظام‬ ‫لضمانأن‬ ‫النهائية‬ ‫المسؤولية‬ ‫الصحية‬ ‫الرعاية‬ ‫موظفو‬ ‫يتحمل‬
،‫والتغليف‬
‫ال‬ ‫وصيانة‬ ‫التعقيم‬ ‫معالجة‬ ‫ل‬ ‫مناسب‬ ‫التعقيم‬ ‫حاويات‬ ‫نظام‬ ‫جامدة‬ ‫ذلك‬ ‫في‬ ‫بما‬
‫عقم‬
.
• The specific design of the rigid sterilization container
system needs to be compatible with the design and
performance of the sterilizer and the devices to be sterilized.
•
‫متوافق‬ ‫النظام‬ ‫يكون‬ ‫أن‬ ‫يجب‬ ‫الصلبة‬ ‫التعقيم‬ ‫لحاوية‬ ‫المحدد‬ ‫التصميم‬
‫التصميم‬ ‫مع‬ ً‫ا‬
‫معقمة‬ ‫تصنيعها‬ ‫المراد‬ ‫واألجهزة‬ ‫التعقيم‬ ‫جهاز‬ ‫أداء‬ ‫و‬
. 18

19. Storage Conditions ‫التخزين‬ ‫شروط‬
• Sterilized items should be stored in a room that is environmentally controlled to maintain optimal conditions
for the sterile integrity of the packages and reduce the potential for contamination.
‫التعقيم‬ ‫لسالمة‬ ‫المثلى‬ ‫الظروف‬ ‫على‬ ‫للحفاظ‬ ً‫ا‬‫بيئي‬ ‫فيها‬ ‫التحكم‬ ‫يتم‬ ‫غرفة‬ ‫في‬ ‫المعقمة‬ ‫العناصر‬ ‫تخزين‬ ‫يجب‬
.
‫وت‬ ‫العبوات‬
‫التلوث‬ ‫احتمالية‬ ‫قليل‬
.
• The sterile storage area, preferably an enclosed room, should be easily accessible from the sterilization areas.
‫التعقيم‬ ‫مناطق‬ ‫من‬ ،‫مغلقة‬ ‫غرفة‬ ‫تكون‬ ‫أن‬ ‫ويفضل‬ ،‫المعقمة‬ ‫التخزين‬ ‫منطقة‬ ‫إلى‬ ‫الوصول‬ ‫السهل‬ ‫من‬ ‫يكون‬ ‫أن‬ ‫يجب‬
.
• It should be designated as a semi-restricted area, requiring those who enter to wear clean scrub attire. It
should also be inaccessible to general
traffic flow patterns or to untrained or unauthorized personnel.
‫نظيفة‬ ‫مالبس‬ ‫ارتداء‬ ‫إليها‬ ‫يدخل‬ ‫من‬ ‫على‬ ‫ويشترط‬ ،‫محظورة‬ ‫شبه‬ ‫كمنطقة‬ ‫تخصيصها‬ ‫وينبغي‬
.
‫ل‬ ‫قابل‬ ‫غير‬ ً‫ا‬‫أيض‬ ‫يكون‬ ‫أن‬ ‫ويجب‬
‫العام‬ ‫إلى‬ ‫لوصول‬
‫لهم‬ ‫مصرح‬ ‫غير‬ ‫أو‬ ‫مدربين‬ ‫غير‬ ‫أفراد‬ ‫إلى‬ ‫أو‬ ‫المرور‬ ‫حركة‬ ‫تدفق‬ ‫أنماط‬
.

20. Storage Conditions ‫التخزين‬ ‫شروط‬
• Sterile items should be stored to protect against contamination and allow for adequate air circulation.
‫كاف‬ ‫بشكل‬ ‫لتدويرالهواء‬ ‫والسماح‬ ‫التلوث‬ ‫من‬ ‫للحماية‬ ‫المعقمة‬ ‫المواد‬ ‫تخزين‬ ‫يجب‬
.
• The shelving must be at least eight inches above the floor, and the bottom shelf must be solid to protect items from
environmental cleaning.
‫البيئ‬ ‫التنظيف‬ ‫من‬ ‫العناصر‬ ‫لحماية‬ ً‫ا‬‫صلب‬ ‫الرف‬ ‫يكون‬ ‫أن‬ ‫يجب‬ ‫واألسفل‬ ‫األرض‬ ‫فوق‬ ‫بوصات‬ ‫ثماني‬ ‫األقل‬ ‫على‬ ‫الرفوف‬ ‫يكون‬ ‫أن‬ ‫يجب‬
‫ي‬
.
• Supplies on the top shelf must be 18 inches below the ceiling or sprinkler heads to ensure sprinkler system
effectiveness.
•
‫العلوي‬ ‫الرف‬ ‫على‬ ‫الموجودة‬ ‫اإلمدادات‬ ‫تكون‬ ‫أن‬ ‫يجب‬
18
‫الرش‬ ‫نظام‬ ‫فعالية‬ ‫لضمان‬ ‫رؤوس‬ ‫الرشاش‬ ‫أو‬ ‫السقف‬ ‫تحت‬ ‫بوصة‬
.
• Shelving units should be at least two inches from outside walls to prevent
contact between sterile items and condensation that could form on the interior surfaces of outside walls.
‫والتكث‬ ‫المعقمة‬ ‫العناصر‬ ‫بين‬ ‫االتصال‬ ‫ذلك‬ ‫لمنع‬ ‫الخارجية‬ ‫الجدران‬ ‫من‬ ‫األقل‬ ‫على‬ ‫بوصتين‬ ‫بعد‬ ‫على‬ ‫الرفوف‬ ‫وحدات‬ ‫تكون‬ ‫أن‬ ‫يجب‬
‫يمكن‬ ‫الذي‬ ‫يف‬
‫الخارجية‬ ‫للجدران‬ ‫األسطحالداخلية‬ ‫على‬ ‫يتشكل‬ ‫أن‬
.